FDA Adverse Event Malfunction Summary report: N

ENDEAVOR RESOLUTE RX

MDR report key: 2851790 · Received November 30, 2012

Report

Report Number: 9612164-2012-01719
Event Type: Malfunction
Date Received: November 30, 2012
Date of Event: October 15, 2012
Report Date: November 5, 2012
Manufacturer: MEDTRONIC IRELAND
Product Code: NIQ
PMA / PMN Number: P110013
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

EVALUATION RESULTS: RELATED TO OPERATIONAL CONTEXT - (DAMAGE ON THE DEVICE IS MOST LIKELY PROCEDURAL RELATED). INHERENT RISK OF PROCEDURE - (FAILURE TO DELIVER STENT AND STENT DEFORMATION) - (DEFORMATION PROBLEM). EVALUATION CONCLUSIONS: RELATED TO OPERATIONAL CONTEXT - (DAMAGE ON THE DEVICE IS MOST LIKELY PROCEDURAL RELATED). INHERENT RISK OF PROCEDURE - FAILURE TO DELIVER STENT AND STENT DEFORMATION.

Description of Event or Problem · 1

THE PHYSICIAN WAS ATTEMPTING TO ADVANCE AN ENDEAVOR RESOLUTE DRUG-ELUTING STENT TO A LESION. THE DEVICE COULD NOT CROSS THE LESION D UE TO STRONG RESISTANCE. IT WAS NOTED ON WITHDRAWAL OF DEVICE THAT THE TIP WAS DEFORMED. NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. THE FIRST THREE DISTAL SEGMENTS WERE RAISED AND DEFORMED. THE BALLOON WAS SCRATCHED AT THE LOCATION OF THE STENT DAMAGE. THE BALLOON WAS INFLATED TO 9ATMS AND 16ATMS WITHOUT ANY ISSUES. THE DISTAL TIP WAS DAMAGED. PLEASE NOTE THAT THIS DEVICE (ENDEAVOR RESOLUTE) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (RESOLUTE INTEGRITY).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENDEAVOR RESOLUTE RX	STENT, CORONARY, DRUG-ELUTING	NIQ	MEDTRONIC IRELAND		0006111366

Patients

Seq	Age	Sex	Outcome	Treatment
1	00043 YR