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

Catalog 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	12/12/2018
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 a revascularisation procedure, it was reported that a dissection occurred during the implantation of a resolute onyx drug eluting stent in the r-pda.This event was treated with another resolute onyx drug eluting stent.
Additional Manufacturer Narrative
It was reported that patient underwent a staged procedure approximately one month post index procedure.Dissection event was reported to be resolved.Site assessed the event as possibly related to the device and not related to the antiplatelets.Index procedure was prompted by silent ischemia.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
During index procedure was one resolute onyx des was implanted in the 2nd obtuse marginal, one in the 2nd diagonal and three in the lad.Cec adjudicated revascularization as no event, this was a staged 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: 8212496
• Report Number: 9612164-2019-00033
• Device Sequence Number: 14113425
• 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,Followup
• Report Date (Section B): 05/08/2019

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: 04/15/2020
• Device Catalogue Number: RONYX22526UX
• Device Lot Number: 0009084983
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 02/28/2019; 04/11/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 03/29/2019; 05/08/2019
• 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: 65 YR
• Patient Weight: 89