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

Model Number RONYX35022UX

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

Patient Problems Myocardial Infarction (1969); Thrombus (2101)

Event Date 01/08/2019

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 rx coronary des were implanted in the obtuse marginal.Approx 17 months later the patient suffered non-stemi (non target vessel).Angio revealed 70-80% stenosis of lad.Investigator assessed event is not related to device or anti platelet medication.The sponsor assessed the event as not related to the device and possibly related to the medication.Revascularization was carried out to treat the lad (non-tvr).The patient recovered.Cec adjudicated non-q-wave mi of target vessel, medtronic extended historical spontaneous in the lad.Cec adjudicated that late stent thrombosis arc definite was noted.

• 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: 9773580
• MDR Text Key: 189305949
• Report Number: 9612164-2020-00942
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557093
• UDI-Public: 00643169557093
• 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: 03/02/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2019
• Device Model Number: RONYX35022UX
• Device Catalogue Number: RONYX35022UX
• Device Lot Number: 0008497043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 03/02/2020
• Date Device Manufactured: 02/15/2017
• 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; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 82