FDA Adverse Event Malfunction Summary report: N

EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM

MDR report key: 1862357 · Received October 8, 2010

Report

Report Number: 2134265-2010-04708
Event Type: Malfunction
Date Received: October 8, 2010
Date of Event: September 16, 2010
Report Date: September 16, 2010
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: FGE
PMA / PMN Number: SIMILAR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PERIPHERAL STENTING TREATMENT PROCEDURE A BALLOON RUPTURE MAY HAVE OCCURRED. THE 90% LESION WAS LOCATED IN THE MODERATELY TORTUOUS EXTERNAL ILIAC ARTERY. THE PHYSICIAN INSERTED THE 7.0X30X75CM EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM AND ENCOUNTERED SOME RESISTANCE AS THE DEVICE WAS ADVANCED ACROSS THE LESION. WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON IT WOULD NOT INFLATE. THE PHYSICIAN STATED THE BALLOON MAY HAVE "RUPTURED" AS IT WAS ADVANCED ACROSS THE LESION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM	CATHETER, BILIARY, DIAGNOSTIC	FGE	BOSTON SCIENTIFIC - GALWAY	H74938162730750	13550920

Patients

Seq	Age	Sex	Outcome	Treatment
1				INTRODUCER SHEATH: 6F TERUMO\| GUIDE WIRE: 0.035 INCH RADIFORCUS