MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING

Catalog Number RSINT25012X

Device Problems Device Expiration Issue (1216); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2016

Event Type  Malfunction  

Event Description

It was reported that the physician was attempting to use a resolute integrity rx drug eluting stent to treat a calcified and tortuous lesion in the mid lcx. It was reported that the lesion was dilated several times but the device failed to cross the target lesion. The device was used approximately 13 days post its use by date.

Manufacturer Narrative

The device was inspected prior to use with no issues noted. The product is sold on consignment. The account have a signed consignment agreement. Patient is stable. Procedure was completed with a resolute onyx drug-eluting stent. Event date updated. Event occurred prior to expiration date. Product was used before expiry date.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6188439
• MDR Text Key: 62796588
• Report Number: 9612164-2016-01334
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (Y/N): N
• Reporter Country Code: RP
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2017

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/20/2016
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 11/22/2016
• Device Catalogue Number: RSINT25012X
• Device LOT Number: 0007377593
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/05/2017
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/23/2014
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial