FDA Adverse Event Injury Summary report: N

TAXUS® LIBERTÉ®

MDR report key: 2880102 · Received December 19, 2012

Report

Report Number: 2134265-2012-07965
Event Type: Injury
Date Received: December 19, 2012
Date of Event: January 4, 2011
Report Date: November 27, 2012
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: NIQ
PMA / PMN Number: P060008
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SD, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(6). DEVICE IS A COMBINATION PRODUCT. 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Description of Event or Problem · 1

(B)(4) STUDY. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, VESSEL DISSECTION OCCURRED. IN (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH AND STABLE ANGINA (CCC CLASS 3) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PROX LAD) WITH 90% STENOSIS AND WAS 8MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT PLACEMENT OF A 3.50X12MM TAXUS LIBERTE STENT. FOLLOWING POST-DILATION, THERE WAS A GRADE A PROXIMAL DISSECTION, WHICH WAS TREATED WITH PLACEMENT OF 3.00X8MM TAXUS LIBERTE STENT OVERLAPPING THE PREVIOUSLY PLACED STUDY STENT DISTALLY. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TAXUS® LIBERTÉ®	CORONARY DRUG-ELUTING STENT	NIQ	BOSTON SCIENTIFIC - MAPLE GROVE	H7493893612350

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR		Required Intervention