PROMUS PREMIER?

Report

Report Number: 2134265-2014-04585
Event Type: Malfunction
Date Received: July 29, 2014
Date of Event: July 3, 2014
Report Date: July 3, 2014
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: P110010
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MANUFACTURER: THE STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND THAT STENT STRUTS FROM THE FOUR MOST DISTAL ROWS OF THE CRIMPED STENT WERE DISTORTED, DEFORMED AND STRETCHED DISTALLY. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON WITHDRAWAL. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE SHAFT POLYMER EXTRUSION PROFILE. 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

SAME CASE AS MDR ID#: 2134265-2014-04586. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 90% STENOSED, 32X4MM, CONCENTRIC AND DE NOVO TARGET LESION WAS LOCATED IN A MILDLY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A .014 GUIDE WIRE WAS ADVANCED AND PREDILATION WAS PERFORMED WITH A 1.5X10MM BALLOON CATHETER. DURING THE PROCEDURE, A 32 X 4.00 PROMUS PREMIER¿ DRUG-ELUTING STENT AND A 16 X 2.75 PROMUS PREMIER¿ DRUG-ELUTING STENT WERE SELECTED TO TREAT THE TARGET LESION; HOWEVER, THE PHYSICIAN ENCOUNTERED DIFFICULTY WITH BOTH DEVICES. NEITHER DEVICE WAS ABLE TO CROSS THE LESION. UPON THE REMOVAL OF EACH DEVICE, BOTH WERE NOTED TO HAVE STRUTS AT THE DISTAL SEGMENT OF THE STENT THAT WERE NOTED TO BE KINKED AND "DETOUCHED" FROM THE STENT DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

Description of Event or Problem · 1

SAME CASE AS MDR ID#: 2134265-2014-04586. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 90% STENOSED, 32X4MM, CONCENTRIC AND DE NOVO TARGET LESION WAS LOCATED IN A MILDLY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. A .014 GUIDE WIRE WAS ADVANCED AND PREDILATION WAS PERFORMED WITH A 1.5X10MM BALLOON CATHETER. DURING THE PROCEDURE, A 32 X 4.00 PROMUS PREMIER¿ DRUG-ELUTING STENT AND A 16 X 2.75 PROMUS PREMIER¿ DRUG-ELUTING STENT WERE SELECTED TO TREAT THE TARGET LESION; HOWEVER, THE PHYSICIAN ENCOUNTERED DIFFICULTY WITH BOTH DEVICES. NEITHER DEVICE WAS ABLE TO CROSS THE LESION. UPON THE REMOVAL OF EACH DEVICE, BOTH WERE NOTED TO HAVE STRUTS AT THE DISTAL SEGMENT OF THE STENT THAT WERE NOTED TO BE KINKED AND "DETOUCHED" FROM THE STENT DELIVERY SYSTEM. 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
442335	PROMUS PREMIER?	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493925132400	16339457

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR