FDA Adverse Event Injury Summary report: N

TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

MDR report key: 1933542 · Received December 21, 2010

Report

Report Number: 2134265-2010-05448
Event Type: Injury
Date Received: December 21, 2010
Date of Event: April 20, 2010
Report Date: November 26, 2010
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: P060008
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS A COMBINATION PRODUCT. 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 FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED RESTENOSIS. THE LESION BEING TREATED WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A TAXUS LIBERTE STENT OF UNKNOWN SIZE WAS IMPLANTED IN THE LESION. IN (B)(6) 2010, THE FOLLOW-UP ANGIOGRAPHY WAS PERFORMED. THE RESULTS FOUND THE TARGET VESSEL WAS 3.50MM, 99% STENOSED AND 10MM LONG. THE PATIENT HAD NO ISCHEMIC SYMPTOMS AT THE TIME OF THE EVENT. THREE DAYS LATER, A NON BSC STENT OF UNKNOWN SIZE WAS IMPLANTED WITH 0% RESIDUAL STENOSIS. THE PATIENT EXPERIENCED NO ANGINAL SYMPTOMS AT THE 9 MONTH AND 1 YEAR FOLLOW-UP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM	CORONARY DRUG-ELUTING STENT	NIQ	BOSTON SCIENTIFIC - GALWAY	UNK433

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention