FDA Adverse Event Malfunction Summary report: N

INTEGRITY RX CORONARY STENT SYSTEM

MDR report key: 2102974 · Received May 12, 2011

Report

Report Number: 9612164-2011-00417
Event Type: Malfunction
Date Received: May 12, 2011
Date of Event: April 11, 2011
Report Date: April 14, 2011
Manufacturer: MEDTRONIC IRELAND
Product Code: MAF
PMA / PMN Number: P030009
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): EVAL: RESULTS: (PT LESION/VESSEL MORPHOLOGY), (FAILURE TO DELIVER STENT). CONCLUSION: (PT LESION/VESSEL MORPHOLOGY). EVAL SUMMARY: THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATION REQUIREMENTS. THE ELEVENTH PROXIMAL STENT SEGMENT WAS RAISED, DAMAGED AND DEFORMED. THE THIRTEENTH STENT SEGMENT WAS DEFORMED.

Description of Event or Problem · 1

THE PHYSICIAN WAS ATTEMPTING TO DEPLOY A 3.0 MM DIAMETER X 22MM LENGTH INTEGRITY RAPID EXCHANGE (RX) BARE METAL STENT TO TREAT A LESION IN THE PROXIMAL TO MID RCA. THE LESION WAS REPORTED TO HAVE BEEN IN A TORTUOUS VESSEL AND EXHIBITED 85 - 95% STENOSIS, WITH CALCIFICATION PRESENT. DESPITE NUMEROUS PRE-DILATIONS, RESISTANCE WAS ENCOUNTERED ATTEMPTING TO DELIVER THE STENT TO THE TARGET LESION. POST REMOVAL OF THE INTEGRITY DEVICE, A HI-TORQUE EXTRA SUPPORT GUIDE WIRE AND PRE-DILATION BALLOON WERE ADVANCED. IT WAS REPORTED THAT THE DAMAGE TO THE STENT SEGMENT WAS OBSERVED DURING PREPARATION OF THE STENT PRIOR TO PLANNED REINSERTION OF THE DEVICE. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED THREE INTEGRITY STENTS AT THE LESION SITE. NO PT INJURY OCCURRED AND NO CLINICAL SEQUELAE WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INTEGRITY RX CORONARY STENT SYSTEM		MAF	MEDTRONIC IRELAND	NA	0005508423

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK