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

Model Number	RONYX25022UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	11/02/2020
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 two resolute onyx des were implanted, one in the 1st diagonal and one in the ramus.Approximately 19 months post procedure the patient suffered acute on chronic congestive heart failure which was treated with salt and fluid restriction, and diuresis.The investigator and sponsor assessed the heart failure as not related to the device or anti-platelet medication.Diagnostic tests also showed coronary calcification with chronically occluded 1st diagonal.Target lesion pci balloon angiography was carried out to treat 100% in- stent restenosis of the 1st diagonal.The investigator and sponsor assessed the cad and occlusion as possibly related to the device and not related to the anti-platelet medication.The patient recovered.

• Brand Name: RESOLUTE ONYX RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11037182
• Report Number: 9612164-2020-04988
• Device Sequence Number: 16415756
• Product Code: NIQ
• UDI-Device Identifier: 00643169556829
• UDI-Public: 00643169556829
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 12/18/2020

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: 04/05/2020
• Device Model Number: RONYX25022UX
• Device Catalogue Number: RONYX25022UX
• Device Lot Number: 0009069815
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/18/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 157