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

Catalog Number RONYX30015UX

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

Patient Problem Thrombus (2101)

Event Date 02/18/2018

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 graft cx.Approximately 6 months post index procedure, patient suffered in-stent coronary artery thrombosis.Event was treated with medication and percutaneous intervention.Investigator assessed that the event was not related to index device and unlikely related to antiplatelet medication.Event was initially reported as stent thrombosis not caused by medtronic stent.However, cec adjudicated the event as late stent thrombosis (arc defined) in the target lesion caused by study stent.Patient is recovered.

Manufacturer Narrative

Cec assessed the event as late stent thrombosis arc definite.During the index procedure the graft of the second obtuse marginal was treated.Event was treated with thrombectomy and the implantation of 3 des in the svg to 2nd obtuse marginal.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The cx was treated during the index procedure safety assessed the event as unlikely to be related to the index device and not related to anti-platelet therapy.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: 8190014
• MDR Text Key: 131171818
• Report Number: 9612164-2018-03765
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556980
• UDI-Public: 00643169556980
• 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: health professional,study,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2019
• Device Catalogue Number: RONYX30015UX
• Device Lot Number: 0008437360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2019
• Date Device Manufactured: 01/04/2017
• 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: 65 YR
• Patient Weight: 117