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

Catalog Number	RONYX30018W
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Death (1802)
Date of Event	04/13/2018
Type of Reportable Event	Death
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 lad.Approximately 8 months post index procedure, patient suffered cerebrovascular accident and died (non-cardiac).Investigator assessed event is not related to study device and unlikely related to antiplatelet.
Additional Manufacturer Narrative
The patient underwent stroke thrombectomy as treatment but it was unsuccessful.The death was assessed as non cardiac.The investigator assessed the event as not related to anti-platelet medication.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: cec adjudicated the death event as vascular death.Cec also adjudicated the stent thrombosis as not an event.Patient has a previous medical history of diabetes mellitus and coronary artery disease.The patient was diagnosed with cerebrovascular accident due to embolism of pure cerebral artery.The cause of death was cerebrovascular accident.If 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: 7551994
• Report Number: 9612164-2018-01262
• Device Sequence Number: 144123
• Product Code: NIQ
• UDI-Device Identifier: 00643169602519
• UDI-Public: 00643169602519
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2018

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: 05/22/2019
• Device Catalogue Number: RONYX30018W
• Device Lot Number: 0008642414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 05/23/2018; 05/23/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 06/06/2018; 12/19/2018
• 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: Death; Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 92