FDA Adverse Event Malfunction Summary report: N

LIBERTE' CORONARY STENT DELIVERY SYSTEM

MDR report key: 1924006 · Received December 14, 2010

Report

Report Number: 2134265-2010-05631
Event Type: Malfunction
Date Received: December 14, 2010
Date of Event: December 8, 2010
Report Date: December 8, 2010
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: MAF
PMA / PMN Number: P040016
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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 RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE TARGET LESION WAS A 99% STENOSED LESION OF THE SEVERELY TORTUOUS, SEVERELY CALCIFIED RIGHT CORONARY ARTERY. PRE-DILATION WAS PERFORMED AND AN ATTEMPT WAS MADE TO CROSS THE LESION WITH A 3.0X16MM LIBERTE STENT. THE DEVICE WAS UNABLE TO CROSS THE LESION AND WAS REMOVED FROM THE PATIENT. DAMAGE WAS NOTED TO THE STENT AFTER REMOVAL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LIBERTE' CORONARY STENT DELIVERY SYSTEM	STENT, CORONARY	MAF	BOSTON SCIENTIFIC - GALWAY	H7493893816300	13513741

Patients

Seq	Age	Sex	Outcome	Treatment
1				6F TERUMO INTRODUCER SHEATH\| RUNTHROUGH GUIDE WIRE\| 6F LAUNCHER JR4 GUIDE CATHETER\| SPRINTER BALLOON CATHETER\| NAMIC INFLATION DEVICE