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

Model Number	RONYX30026UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	03/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During index procedure, a resolute onyx drug-eluting stent was implanted in the cx.Four days post procedure, patient suffered cardiogenic shock and was treated with blood transfusion and vasopressors.Patient not recovered.Investigator and sponsor assessed event is not related to device or anti platelet medication.Cec adjudicated non-q-wave mi of unknown vessel, 3rd udmi spontaneous.Cec commented mi from cardiogenic shock/bleeding - outside of peri-pci window.No side branch occlusion occurred.

• Brand Name: RESOLUTE ONYX RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• MDR Report Key: 9731606
• Report Number: 9612164-2020-00801
• Device Sequence Number: 2401671
• Product Code: NIQ
• UDI-Device Identifier: 00643169557017
• UDI-Public: 00643169557017
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2020
• Device Model Number: RONYX30026UX
• Device Catalogue Number: RONYX30026UX
• Device Lot Number: 0009432818
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Weight: 81