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

Catalog Number RSINT35026UX

Device Problem Device Expiration Issue (1216)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician was attempting to use a resolute integrity drug eluting stent to treat a lesion in the rca.No damage to device packaging and no issues removing device from hoop/tray.Device was inspected and negative prep performed with no issues noted.It was reported that the stent was implanted approximately 16 days post expiry date.No patient injury or medical/surgical intervention reported.The patient is fine.

• 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: 6885689
• MDR Text Key: 87882874
• Report Number: 9612164-2017-01304
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169037144
• UDI-Public: 00643169037144
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2017
• Device Catalogue Number: RSINT35026UX
• Device Lot Number: 0007680982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/22/2017
• Date Device Manufactured: 08/10/2015
• 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