FDA Adverse Event Malfunction Summary report: N

RESOLUTE INTEGRITY RX

MDR report key: 2830045 · Received November 13, 2012

Report

Report Number: 9612164-2012-01646
Event Type: Malfunction
Date Received: November 13, 2012
Date of Event: October 16, 2012
Report Date: October 17, 2012
Manufacturer: MEDTRONIC IRELAND
Product Code: NIQ
PMA / PMN Number: P110013
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION RESULTS AND CONCLUSION: (STENT DAMAGE, FAILURE TO DELIVER THE STENT). (TARGET LESION EXHIBITED SEVERE CALCIFICATION). (USE OF FORCE TO ADVANCE THE DEVICE).

Description of Event or Problem · 1

THE PHYSICIAN INTENDED TO USE A 3.0 X 38 MM RESOLUTE INTEGRITY RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A LESION IN THE MID RCA. THE TARGET LESION EXHIBITED 80% STENOSIS AND SEVERE CALCIFICATION. LESION PRE-DILATION WAS PERFORMED. APPROXIMATELY 20% STENOSIS REMAINED FOLLOWING PRE-DILATION. RESISTANCE WAS ENCOUNTERED DURING THE ATTEMPT TO ADVANCE THE RESOLUTE INTEGRITY DEVICE AND FORCE WAS USED IN THE EFFORT TO ADVANCE. THE DEVICE FAILED TO CROSS THE LESION AND WAS REMOVED. THE STENT WAS OBSERVED TO BE DAMAGED ON REMOVAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER RESOLUTE INTEGRITY STENT. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. POST PROCEDURE PATIENT STATUS WAS REPORTED TO BE GOOD AND NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. A NUMBER OF STRUTS ON THE 1ST PROXIMAL STENT SEGMENT WERE RAISED AND OVERLAPPING. A NUMBER OF STRUTS ON THE 9TH, 10TH AND 16TH PROXIMAL SEGMENTS WERE PARTIALLY RAISED AND DEFORMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RESOLUTE INTEGRITY RX	STENT, CORONARY, DRUG-ELUTING	NIQ	MEDTRONIC IRELAND		0006307268

Patients

Seq	Age	Sex	Outcome	Treatment
1	00050 YR