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

Model Number RONYX22538UX

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

Patient Problems Occlusion (1984); Stenosis (2263); Injury (2348)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the index procedure one resolute onyx drug eluting stent (ronyx22538ux) was implanted in the lad.One resolute onyx drug eluting stent (ronyx22522ux) was implanted in the cx during a planned staged procedure.On the same day as the staged procedure the patient suffered in-stent coronary artery restenosis treated with revascularization of the lad (cass 13).The patient recovered.The investigator assessed the event as not related to the anti-platelet medication or the device.The sponsor assessed the event as not related to the anti-platelet medication and possibly related to the device.Cec adjudicated the revascularization as no event and commented "no change.Staged procedure with plaque shift from ostial lcx and distal left main to ostial lad prompting rescue of lad." safety commented isr.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 9835794
• MDR Text Key: 189476371
• Report Number: 9612164-2020-01195
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556775
• UDI-Public: 00643169556775
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2020
• Device Model Number: RONYX22538UX
• Device Catalogue Number: RONYX22538UX
• Device Lot Number: 0009318351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2020
• Date Device Manufactured: 09/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 73