PROMUS ELEMENT ? LONG

Report

Report Number: 2134265-2014-03684
Event Type: Malfunction
Date Received: June 30, 2014
Date of Event: January 21, 2014
Report Date: June 5, 2014
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: SIMILAR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR.: A VISUAL AND TACTILE EXAMINATION OF THE DEVICE FOUND THAT THE STENT WAS DAMAGED AT THE DISTAL END; A STRUT WAS STRETCHED AND LIFTED UPWARDS FROM ITS PROFILE. THE HYPOTUBE WAS KINKED 230MM DISTAL FROM THE STRAIN RELIEF. NO OTHER ISSUES WERE NOTED WITH THE DEVICE; THE BALLOON WAS TIGHTLY WRAPPED AND DID NOT APPEAR TO HAVE BEEN SUBJECTED TO POSITIVE PRESSURE. 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

REPORTABLE BASED ON ANALYSIS APPROVED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 80% STENOSED, 3X34MM ECCENTRIC TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PREDILATED AND THEN A 2.75X38MM PROMUS ELEMENT ¿ LONG STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LAD BUT WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
381285	PROMUS ELEMENT ? LONG	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493911338270	16354416

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR