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

Catalog Number RSINT22526UX

Device Problem Device Expiration Issue (1216)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2017

Event Type  malfunction  

Event Description

It was reported that a resolute integrity rx drug eluting stent was implanted approximately 7 months post its expiry date.No patient injury or medical/surgical intervention was required.It was reported that the product was on consignment at the account.The account has a signed consignment agreement and are responsible for controlling short dated/expired product.Patient reported as ok.

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: 6553414
• MDR Text Key: 74701293
• Report Number: 9612164-2017-00569
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169037441
• UDI-Public: 00643169037441
• Combination Product (y/n): N
• Reporter Country Code: DR
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: RSINT22526UX
• Device Lot Number: 0007926999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2017
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1