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

Catalog Number RONYX40018UX

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

Patient Problems Thrombus (2101); Injury (2348)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the index procedure, two resolute onyx drug eluting stents were deployed, one in the first diagonal and one in the proximal circumflex.Approximately 10 months later, the patient presented with unstable anginal pain.Angio showed severe in-stent restenosis with in-stent thrombus to the vein graft supplying the first diagonal.The patient was hospitalized and revascularization of the first diagonal carried out.Patient recovered.The site assessed that the event was unlikely related to the antiplatelet medication and probably device related.The sponsor assessed that the event was possibly related to the anti platelet medication and possibly device related.

Manufacturer Narrative

Patient was treated with medication.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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9233328
• MDR Text Key: 163914385
• Report Number: 9612164-2019-04498
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557178
• UDI-Public: 00643169557178
• 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,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2020
• Device Catalogue Number: RONYX40018UX
• Device Lot Number: 0009059706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2019
• Date Device Manufactured: 04/03/2018
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 108