FDA Adverse Event Injury Summary report: N

TAXUS® LIBERTÉ®

MDR report key: 2831980 · Received November 14, 2012

Report

Report Number: 2134265-2012-07076
Event Type: Injury
Date Received: November 14, 2012
Date of Event: June 3, 2010
Report Date: October 18, 2012
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: NIQ
PMA / PMN Number: P060008
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS A COMBINATION PRODUCT. (B)(6). 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

(B)(4). IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, PINCHING OF THE OSTIUM OF DIAGONAL OCCURRED. IN (B)(6) 2010, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH REVEALED AN 80% STENOSED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.9 MM AND TREATED WITH DIRECT STENT PLACEMENT USING A 3.50 X 24 MM TAXUS LIBERTE STENT. POST STENT DEPLOYMENT, PINCHING OF THE OSTIUM OF DIAGONAL (80% OSTIAL STENOSIS) WAS NOTED AND TREATED USING A 2.5 X 12 MM NON-BSC BALLOON WITH 40% RESIDUAL STENOSIS IN DIAGONAL BRANCH. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0% AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL THE FOLLOWING DAY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TAXUS® LIBERTÉ®	CORONARY DRUG-ELUTING STENT	NIQ	BOSTON SCIENTIFIC - MAPLE GROVE	H7493893724350	13392352

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR		Required Intervention