FDA Adverse Event Death Summary report: N

TAXUS® LIBERTÉ® ATOM?

MDR report key: 3910371 · Received July 2, 2014

Report

Report Number: 2134265-2014-03729
Event Type: Death
Date Received: July 2, 2014
Date of Event: February 2, 2012
Report Date: June 5, 2014
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: P060008
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 70% STENOSIS AND WAS 28MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 2.25X32MM TAXUS LIBERTE STENT, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE PATIENT WAS DISCHARGED ON ASPIRIN, PLAVIX, DIGOXIN, CARDIZEM CD, LISINOPRIL, LIPITOR, METOPROLOL, OXY-CONTIN, OXYCODONE AND SL NITRO PRN. IN (B)(6) 2012, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
388568	TAXUS® LIBERTÉ® ATOM?	CORONARY DRUG-ELUTING STENT	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493893632220	12648390

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR		Death