FDA Adverse Event Injury Summary report: N

EXPRESS¿ LD VASCULAR

MDR report key: 2822154 · Received November 7, 2012

Report

Report Number: 2134265-2012-06821
Event Type: Injury
Date Received: November 7, 2012
Date of Event: October 9, 2012
Report Date: October 9, 2012
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: FGE
PMA / PMN Number: SIMILAR
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).DEVICE EVALUATED BY MANUFACTURER: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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A STENT DISLODGED. VASCULAR ACCESS WAS OBTAINED VIA AN FEMORAL IPSILATERAL APPROACH. THE 90% STENOSED TARGET LESION WAS LOCATED IN SEVERELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. A 8.0X40X75CM EXPRESS LD VASCULAR STENT DELIVERY SYSTEM (SDS) ENCOUNTERED DIFFICULTY CROSSING THE TARGET LESION. WHEN THE EXPRESS LD VASCULAR SDS WAS PUSHED THE STENT DISLODGED AT THE DISTAL OF THE TARGET LESION. THE EXPRESS LD VASCULAR STENT WAS IMPLANTED AT THE DISLODGED LOCATION. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND NO ADDITIONAL ACTIONS WERE TAKEN. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	EXPRESS¿ LD VASCULAR	CATHETER, BILIARY, DIAGNOSTIC	FGE	BOSTON SCIENTIFIC - GALWAY	H74938162840750	14976370

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other