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

Catalog Number	RONYX35030UX
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	07/02/2018
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 index procedure, three resolute onyx drug-eluting stents were implanted.Two in the rca and one in the ist om.Approximately 12 months post procedure, patient suffered possible nstemi and was treated with pci.Investigator assessed event is not related to the study device or antiplatelet.Patient recovered.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Target (culprit) vessel involved was rca.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The patient was treated with medication.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cec assessed the mi as no event.This 'no event' occurred approximately 13 months post procedure.Cec assessed the revascularization as a tlr percutaneous intervention that was clinically driven (proximal rca was indicated as the location by cec).During the index procedure, one stent was implanted in the 2nd obtuse marginal, and not the 1st obtuse marginal as previously reported.It was also reported that the patient underwent heart catheterization approximately 13 months post procedure.An angiogram showed 100% in stent restenosis of proximal rca.Interventionist was unable to advance the guide wire across the rca, and the rca was left untreated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7705611
• Report Number: 9612164-2018-01801
• Device Sequence Number: 19210156
• Product Code: NIQ
• UDI-Device Identifier: 00643169557116
• UDI-Public: 00643169557116
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup,Followup
• Report Date (Section B): 12/13/2018

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: 02/20/2019
• Device Catalogue Number: RONYX35030UX
• Device Lot Number: 0008504599
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/10/2018; 10/09/2018; 11/14/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 10/02/2018; 10/04/2018; 11/06/2018; 12/13/2018
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 107