FDA Adverse Event Injury Summary report: N

TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

MDR report key: 1911050 · Received November 30, 2010

Report

Report Number: 2134265-2010-05283
Event Type: Injury
Date Received: November 30, 2010
Date of Event: August 25, 2010
Report Date: November 3, 2010
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)(4): 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 TREATMENT PROCEDURE THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN THE 1ST OBTUSE MARGINAL WITH 80% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 2.25 MM X 16 MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. FOLLOWING THE INDEX PROCEDURE THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. CARDIAC ENZYME ELEVATION OCCURRED WITH PEAK TROPONIN 0.98NG/ML, ULN 0.05 NG/ML. ECG PERFORMED ((B)(6) 2010) REVEALED MARKED BRADYCARDIA. NO ACTION WAS TAKEN AND THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL.

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 - MAPLE GROVE	H7493893616220	13512011

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Other