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

Model Number	RONYX40038UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Embolism (1829)
Date of Event	02/16/2019
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 the index procedure two resolute onyx stents were implanted to treat the rca.Approximately 6 days post index procedure the patient suffered arm discomfort.It was reported that the patient may have suffered a possible embolic event.Stroke did not occur.The investigator and safety assessed the event as not related to the index device or anti-platelet medication.The patient is recovering.
Additional Manufacturer Narrative
Event date changed to (b)(6) 19.Ae term changed to acute spinal cord infarct confirmed by mri.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: cec adjudicated the event as stroke, ischemic.Cec commented that the acute spinal cord injury was post procedure.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: 8564645
• Report Number: 9612164-2019-01515
• Device Sequence Number: 11281105
• Product Code: NIQ
• UDI-Device Identifier: 00643169557222
• UDI-Public: 00643169557222
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup,Followup
• Report Date (Section B): 02/06/2020

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: 08/15/2019
• Device Model Number: RONYX40038UX
• Device Catalogue Number: RONYX40038UX
• Device Lot Number: 0008755706
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 07/17/2019; 01/31/2020
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 08/01/2019; 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 56