ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

Report

Report Number: 9612164-2011-00153
Event Type: Malfunction
Date Received: April 6, 2011
Date of Event: February 28, 2011
Report Date: March 8, 2011
Manufacturer: MEDTRONIC IRELAND
Product Code: NIQ
PMA / PMN Number: P060033
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): RESULTS: (LESION MORPHOLOGY), (FAILURE TO DELIVER STENT AND STENT DEFORMATION), (USE OF FORCE TO ADVANCE THE STENT). CONCLUSION: (LESION MORPHOLOGY), (USE OF FORCE TO ADVANCE THE STENT). EVALUATION SUMMARY: A NUMBER OF STRUTS ON THE 17TH AND 18TH PROXIMAL STENT SEGMENT WERE PARTIALLY RAISED AND DEFORMED THE DISTAL TIP WAS SLIGHTLY FLARED.

Description of Event or Problem · 1

THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 3.0 MM DIAMETER X 30MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG ELUTING IN A PATIENT. IT WAS REPORTED THAT THE PATIENT HAD A LESION EXHIBITING 95% STENOSIS IN THE MID LCX AND A LESION EXHIBITING 99% STENOSIS IN THE DISTAL RCA, HOWEVER IT IS UNCLEAR WHICH LESION THE PHYSICIAN ATTEMPTED TO TREAT USING THE RESOLUTE STENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE LESION WAS PRE-DILATED. INFORMATION RECEIVED CONFIRMED THAT RESISTANCE WAS ENCOUNTERED AND FORCE WAS APPLIED IN AN ATTEMPT TO DELIVER THE STENT ACROSS THE LESION. THE PHYSICIAN COULD NOT POSITION THE STENT. AFTER TWO ATTEMPTS THE PATIENT EXPERIENCED CHEST TIGHTNESS AND THE PHYSICIAN ABANDONED THE SURGERY. THE PATIENT FELT WELL ONE HOUR LATER. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM		NIQ	MEDTRONIC IRELAND	NA	0003695486

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK