MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX OTW; CORONARY DRUG-ELUTING STENT

Model Number RONYX30012W

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a procedure prompted by stemi an attempt was made to use one resolute onyx coronary drug eluting stent to treat an 100% occluded lesion in the obtuse marginal (om) artery.There was no damage noted to the device packaging.There were no issues noted removing the device from the protective hoop.The device was inspected prior to use.It was reported that the device was implanted in the patient approx.2 weeks post expiry date.It was stated that timi was 3 before stent implantation and timi 0 after stent deployment.No patient injury was reported.

• Brand Name: RESOLUTE ONYX OTW
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12272755
• MDR Text Key: 264930710
• Report Number: 9612164-2021-02986
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169602496
• UDI-Public: 00643169602496
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• 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: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2021
• Device Model Number: RONYX30012W
• Device Catalogue Number: RONYX30012W
• Device Lot Number: 0009822930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2021
• Date Device Manufactured: 07/13/2019
• 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
• Patient Age: 50 YR
• Patient Weight: 97