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

Catalog Number RONYX25015X

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Angina (1710); Myocardial Infarction (1969)

Event Date 06/29/2018

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 des was implanted in the 1st obtuse marginal.Approximately 4 days later the patient suffered exertional angina.It was indicated that the exertional angina was related to a myocardial infarction.It is unknown if the target vessel was involved.Investigator assessed the event as possibly related to the index device and unlikely related to the anti-platelet medication.Patient is recovering.

Manufacturer Narrative

Event date was updated.The event term was updated to myocardial infarction.Investigator assessed that the event was not related to index device or anti-platelet medication.The sponsor assessed the event as possibly related to anti-platelet medication.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Sponsor assessed the event as not related to the index device.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

The event was treated by revascularization with the implantation of one resolute onyx des in the lad.This has been classified as a non target lesion revascularization and the target vessels were not involved.Cec adjudicated the mi as non q wave mi (non target vessel) and adjudicated the revascularization as non tvr percutaneous intervention (ntvr).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Cec adjudicated that the mi was a non event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The patient recovered.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: 7689061
• MDR Text Key: 114007539
• Report Number: 9612164-2018-01738
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2019
• Device Catalogue Number: RONYX25015X
• Device Lot Number: 0008798068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2019
• Date Device Manufactured: 07/26/2017
• 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
• Patient Age: 82 YR
• Patient Weight: 73