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

Model Number	RONYX30012W
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12272755
• Report Number: 9612164-2021-02986
• Device Sequence Number: 3611842
• Product Code: NIQ
• UDI-Device Identifier: 00643169602496
• UDI-Public: 00643169602496
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2021

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 97