October 8, 1998
Dear Colleague:
This is to alert you to a serious problem with the NIR ONÔ RangerÔ w/SOX Ô PREMOUNTED STENT SYSTEM manufactured by Boston Scientific/SCIMED (Maple Grove, MN). We have received reports of device failures, including: balloon ruptures leading to vessel dissection; balloon leaks resulting in incomplete stent deployment and/or stent migration; and difficulty deflating and removing the stent delivery system. At this time, the manufacturer is aware of one patient death and 26 patient injuries associated with these failures. The manufacturer is currently conducting a total market withdrawal of the catheter.
Cause of problem
We have recently learned that the balloon portion of the delivery catheter develops pinhole leaks and ruptures at inflation pressures as low as 3 ATM. This problem manifests during the stent deployment procedure. Preliminary failure investigation conducted by the manufacturer indicates that the cause of the balloon problem appears to be related to the SOXÔ manufacturing process.
Recommendations
The FDA considers Boston Scientific/SCIMED’s market withdrawal of the product as a total product recall. We believe the use of this defective product poses a substantial risk to patients. We recommend that you take the following actions:
1. Immediately discontinue use of the product. We have information indicating that these device failures may result in emergency interventions, including coronary bypass surgery.
2. Return all unused catheters to the manufacturer. Boston Scientific/SCIMED will exchange the affected product with the NIR ONÔ RangerÔ without SOXÔ at no cost.
3. Contact the manufacturer for product specific information. For further information regarding the product recall and exchange program, call the SCIMED customer service line at 888-724-6334.
Background information
The NIR ONÔ RangerÔ w/SOXÔ Premounted Stent System is a coronary artery stent delivery system. It was approved for commercial distribution on August 12, 1998 and is available in 12 models. As stated in the product labeling, the catheter is indicated for use in:
Reporting adverse events
FDA is interested in obtaining data on malfunctions and adverse events involving this device. Practitioners who are employed by health care facilities that are subject to FDA’s user facility reporting requirements should follow the reporting procedures established by their facility. All other practitioners may submit these reports directly to MedWatch, FDA’s voluntary reporting program. The reports may be submitted by phone at 800-FDA-1088, by fax at 800-FDA-0178, by internet at www.fda.gov/medwatch, or by mail to: MedWatch, FDA, HF-2, 5600 Fishers Lane, Rockville, MD 20857.
Getting more information
If you have any questions regarding this letter, please contact Bram Zuckerman, MD, CDRH, FDA, 9200 Corporate Boulevard, Mail Stop HFZ- 450, Rockville, MD 20850; by fax at 301-480-4204 or by e-mail at bdz@cdrh.fda.gov.
All of FDA’s medical device postmarket safety notifications can be found on the World Wide Web at http://www.fda.gov/cdrh/safety.html. Postmarket safety notifications can also be obtained through e-mail on the day they are released by subscribing to our list server. To subscribe, visit http://service.govdelivery.com/service/subscribe.html?code=USFDACDRH_10 Additional safety information is available at www.fda.gov/medwatch/safety.htm.
| Sincerely yours, | ||
| Larry G. Kessler, Sc.D. | ||
| Director | ||
| Office of Surveillance and Biometrics | ||
| Center for Devices and | ||
| Radiological Health |
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Updated October 8, 1998
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