TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Report

Report Number: 2134265-2010-04768
Event Type: Injury
Date Received: October 28, 2010
Date of Event: October 5, 2010
Report Date: October 11, 2010
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: NIQ
PMA / PMN Number: P030025
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
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

SAME CASE AS MFR#: 2134265-2010-04779. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT HAD AN MI AND STENT THROMBOSIS. THE TARGET LESION WAS LOCATED IN THE PROXIMAL TO MID CIRCUMFLEX (CX). TWO TAXUS EXPRESS STENTS, SIZE 2.25X24MM AND 2.75X16MM, WERE DEPLOYED OVERLAPPING IN THE CX. NO COMPLICATIONS OCCURRED DURING THE INITIAL PROCEDURE. THE PATIENT WAS ADMINISTERED PLAVIX. EIGHTEEN MONTHS LATER, THE PATIENT WAS SCHEDULED FOR AN UNSPECIFIED SURGERY AND STOPPED TAKING PLAVIX. TWO WEEKS LATER, THE PATIENT PRESENTED EMERGENTLY WITH A MYOCARDIAL INFARCTION AND THROMBOSIS IN THE CX. A BALLOON CATHETER WAS USED TO TREAT THE VESSEL AND A 2.5X18MM PROMUS STENT WAS DEPLOYED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM	CORONARY DRUG-ELUTING STENT	NIQ	BOSTON SCIENTIFIC - MAPLE GROVE	UNK432

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Required Intervention