TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Report

Report Number: 2134265-2010-05343
Event Type: Injury
Date Received: December 2, 2010
Date of Event: November 5, 2010
Report Date: November 8, 2010
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: NIQ
PMA / PMN Number: P060008
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND AND MET ALL SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

Description of Event or Problem · 1

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

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	H7493893620250	13249679

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Required Intervention