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

Catalog Number RONYX50030UX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Patient Problem/Medical Problem (2688)

Event Date 09/27/2017

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During the index procedure three resolute onyx des were implanted in the 1st diag, lcma and cx.On the same day, coronary artery plaque shift into the 1st om was reported.This was treated with an unknown branded balloon.Approximately three months later another resolute onyx des was implanted for target lesion treatment.The investigator assessed the event as probably related to the device and not related to the antiplatelet medication.The patient recovered.[update (b)(6) 2018 also reviewed.].

Manufacturer Narrative

Correction: patient age.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: cec adjudicated mi as no event, but revascularization of the lcma, cm, 1st om and graft 1st diag are due to stent thrombosis event type.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8132207
• MDR Text Key: 129297150
• Report Number: 9612164-2018-03468
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2019
• Device Catalogue Number: RONYX50030UX
• Device Lot Number: 0008523355
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 109