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

Model Number RONYX25022UX

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

Patient Problems Thrombus (2101); Patient Problem/Medical Problem (2688)

Event Date 10/23/2018

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 prox cx.Approximately 7 months later, a second resolute onyx des was implanted in a new lesion.Approximately 7 months later (and 14 months after the index procedure) two additional resolute onyx des were then implanted during a revascularization procedure.Approximately one month later (and 15 months post index procedure) svf to lcx vein graft thrombosis was reported.It was reported that the lcx was involved and that the thrombosis occurred in a resolute onyx des.The patient was hospitalized and received thrombectomy using a medtronic export ap expiration catheter.The patient recovered.The investigator assessed the event as not related to the device but possibly related to the antiplatelet medication.The patient recovered.

Manufacturer Narrative

The ae term was updated to coronary artery stent thrombosis.During the revascularization 7 months post index and the revascularization 14 months post index procedure, resolute onyx des were implanted to treat new lesions in the graft cx, these are consider to be target vessel revascularizations.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: cec adjudicated the stent thrombosis end point as late stent thrombosis arc defined.Graft 2nd obtuse marginal.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: 8110319
• MDR Text Key: 128582217
• Report Number: 9612164-2018-03399
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556829
• UDI-Public: 00643169556829
• 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,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2019
• Device Model Number: RONYX25022UX
• Device Catalogue Number: RONYX25022UX
• Device Lot Number: 0008824232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2020
• Date Device Manufactured: 10/05/2017
• 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