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

Catalog Number RONYX35022X

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

Patient Problems Death (1802); Ventricular Tachycardia (2132)

Event Date 03/16/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

During the index procedure one resolute onyx was implanted in the graft 1st diagonal.Four non medtronic des devices were also implanted.Approximately 13 months later the patient suffered ventricular tachycardia and this was treated with medication and a temporary pacemaker was inserted.The patient died a non sudden cardiac death.The patient was not taking dual anti-platelet therapy within 24 hours of the event.The investigator and sponsor assessed that the event was not related to the device or anti-platelet medication.

Manufacturer Narrative

Additional information: during the index procedure 3 non medtronic stents were implanted in the graft 1st diagonal.During a staged procedure a non medtronic stent was implanted in the cx.During a revascularization 13 months post index procedure a resolute onyx des was implanted in the graft 1st diagonal.Patient did not die as previously reported.Patient is not 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: 8521735
• MDR Text Key: 142176507
• Report Number: 9612164-2019-01362
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: LO
• 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
• Report Date: 04/26/2019

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: 11/13/2020
• Device Catalogue Number: RONYX35022X
• Device Lot Number: 0009432803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/17/2019
• Supplement Dates Manufacturer Received: 03/20/2019
• Supplement Dates FDA Received: 04/26/2019
• Date Device Manufactured: 11/14/2018
• 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): Death; Hospitalization; Other; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 65