FDA Adverse Event Injury Summary report: N

TAXUS® LIBERTÉ®

MDR report key: 2936198 · Received January 30, 2013

Report

Report Number: 2134265-2013-00224
Event Type: Injury
Date Received: January 30, 2013
Date of Event: December 28, 2012
Report Date: January 4, 2013
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: P060008
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PATIENT IDENTIFIER: (B)(4). 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. SAME CASE AS MDR ID#: 2134265-2013-00223. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD RESTENOSIS IN THE STENTED VESSEL. IN (B)(6) 2009, THE PATIENT HAD MYOCARDIAL INFARCTION. TWO TAXUS LIBERTE STENTS OF SIZE 3.5X32MM AND 3.5X16 MM WERE PLACED IN THE PROXIMAL RIGHT CORONARY ARTERY (PROX RCA). IN (B)(6) 2012, THE SITE REPORTED AN EVENT OF CORONARY ARTERY DISEASE AND THE PATIENT WAS HOSPITALIZED. CORONARY ANGIOGRAPHY REVEALED 70% STENOSIS IN THE MID RCA, WHICH WAS TREATED WITH PLACEMENT OF A 2.75X20MM PROMUS ELEMENT PLUS STENT WITH 0% RESIDUAL STENOSIS. THE EVENT WAS RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
40743	TAXUS® LIBERTÉ®	CORONARY DRUG-ELUTING STENT	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493893616350	12558918

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR		Hospitalization\| R