FDA Adverse Event Injury Summary report: N

TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

MDR report key: 1781989 · Received August 3, 2010

Report

Report Number: 2134265-2010-03305
Event Type: Injury
Date Received: August 3, 2010
Date of Event: July 2, 2010
Report Date: July 6, 2010
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: NIQ
PMA / PMN Number: P060008
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINANT 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 REPORT #: 2134265-2010-03306. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A VESSEL PERFORATION OCCURRED. THE LESION WAS LOCATED IN AN 11 YEAR OLD SAPHENOUS VEIN GRAFT (SVG). THE PHYSICIAN ADVANCED A FILTERWIRE AND DEPLOYED A TAXUS LIBERTE' STENT OF UNKNOWN SIZE IN THE LESION. THE FILTERWIRE WAS ACCIDENTALLY PULLED THROUGH THE STENT WITHOUT PLACING THE DEVICE INTO THE RETRIEVAL SHEATH AND WAS REMOVED IN AN OPEN LOOP STATE. ANGIOGRAPHY AT THE END OF THE CASE REVEALED A PERFORATION. THE PATIENT WAS STABLE WHEN DISCHARGED FROM THE HOSPITAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE.

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	UNK433

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other	BOSTON SCIENTIFIC FILTERWIRE