FDA Adverse Event Malfunction Summary report: N

LIBERTÉ?

MDR report key: 3972789 · Received August 1, 2014

Report

Report Number: 2134265-2014-04538
Event Type: Malfunction
Date Received: August 1, 2014
Date of Event: July 9, 2014
Report Date: July 9, 2014
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). RETURNED PRODUCT CONSISTED OF A LIBERTE STENT DELIVERY SYSTEM (SDS) WITH STENT AND NO OTHER DEVICES. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT SECURED ON THE BALLOON. THE FOURTH PROXIMAL ROW OF STENT STRUTS WAS FLARED, BENT AND OVERLAPPING. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE OR THE REPORTED CROSSING DIFFICULTY. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/ PROCEDURAL FACTORS. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX (LCX) ARTERY. A 3.50MM X 20MM LIBERTÉ¿ BARE METAL STENT WAS SELECTED FOR USE AND ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND ITS STENT STRUT WAS DEFORMED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
451053	LIBERTÉ?	STENT, CORONARY	MAF	BOSTON SCIENTIFIC - MAPLE GROVE	H7493893820350	16554439

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR