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

Model Number	RONYX22526UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	12/18/2018
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 the cx was treated with two resolute onyx des.Dissection was reported in the target area.
Additional Manufacturer Narrative
The index procedure was prompted by evidence of ischemia and unstable angina.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: 9503588
• Report Number: 9612164-2019-05279
• Device Sequence Number: 2982066
• Product Code: NIQ
• UDI-Device Identifier: 00643169556744
• UDI-Public: 00643169556744
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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: 03/22/2020
• Device Model Number: RONYX22526UX
• Device Catalogue Number: RONYX22526UX
• Device Lot Number: 0009046168
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 82