FDA Adverse Event Malfunction Summary report: N

VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM

MDR report key: 2140281 · Received June 27, 2011

Report

Report Number: 2134265-2011-02636
Event Type: Malfunction
Date Received: June 27, 2011
Date of Event: June 15, 2011
Report Date: June 15, 2011
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: MAF
PMA / PMN Number: P040016
Product Problem: Yes
Report Source: Manufacturer report
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

IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN AN UNKNOWN SEVERELY CALCIFIED ARTERY. THE PHYSICIAN ATTEMPTED TO ADVANCE THE 3.5X8MM VERIFLEX STENT AND ENCOUNTERED RESISTANCE ADVANCING AND THE DEVICE WOULD NOT CROSS THE LESION. UPON REMOVAL, IT WAS NOTED THAT THE STENT STRUT WAS LIFTED. PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VERIFLEX (LIBERTE) CORONARY STENT DELIVERY SYSTEM	STENT, CORONARY	MAF	BOSTON SCIENTIFIC - MAPLE GROVE	H749389348350	11832466

Patients

Seq	Age	Sex	Outcome	Treatment
1