EXPRESS? LD VASCULAR

Report

Report Number: 2134265-2014-02363
Event Type: Injury
Date Received: May 5, 2014
Date of Event: April 7, 2014
Report Date: April 7, 2014
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

AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR.: 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 STENT FRACTURE OCCURRED. ON (B)(6) 2014, THE PATIENT HAD A 100% STENOSED, CHRONIC TOTAL OCCLUSION (CTO) TARGET LESION LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS COMMON ILIAC ARTERY (CIA). THE LESION WAS TREATED WITH PRE-DILATATION AND IMPLANTATION OF A 8.0 X 60 X 75CM EXPRESS LD VASCULAR STENT. ON (B)(6) 2014, PATIENT RETURNED FOR A FOLLOW UP ANGIOGRAPHY. IT REVEALED THAT THE STENT WAS SEPARATED INTO HALF AND SOMETHING WHITE "SMOKE LIKE" WAS NOTED UNDER ANGIOGRAPHY. NO INTERVENTION WAS PERFORMED TO TREAT THE EVENT. PATIENT WAS SCHEDULED FOR A FOLLOW CHECK UP 6 MONTHS LATER. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT'S STATUS WAS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
266538	EXPRESS? LD VASCULAR	CATHETER, BILIARY, DIAGNOSTIC	FGE	BOSTON SCIENTIFIC - GALWAY	H74938162860750	15473193

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other	INTRODUCER SHEATH: 7F\| INFLATION DEVICE: MEDTRO