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

Catalog Number	RONYX35012W
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Patient Problem/Medical Problem (2688)
Date of Event	06/13/2018
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 the index procedure one resolute onyx des was implanted in the mid lad.A second resolute onyx was also implanted 6 months later.Approximately 9 months post index procedure the patient suffered a cardiac arrest in the lad.This was treated with one drug eluting stent.The patient recovered.The investigator reported that the event is not related to the index device or anti platelet medication.Safety assessment reported that the event is not related to the device, antiplatelet medication or procedure.
Additional Manufacturer Narrative
The second resolute onyx des was implanted in the lad on (b)(6) 2018 to treat the event, not (b)(6) 2018 as previously reported.The patient was also treated with surgical intervention, with the implantation of a defibrillator.Cec adjudicated the event as 'tvr percutaneous intervention not involving thetarget lesion, and not clinically driven.' if information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: cec re-adjudicated the tvr pci not involving the target lesion as clinically driven.Information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX OTW
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7800363
• Report Number: 9612164-2018-02106
• Device Sequence Number: 16735710
• Product Code: NIQ
• UDI-Device Identifier: 00643169602588
• UDI-Public: 00643169602588
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2019

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: 02/07/2019
• Device Catalogue Number: RONYX35012W
• Device Lot Number: 0008486285
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 11/02/2018; 01/31/2019
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 11/30/2018; 02/27/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 140