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

Model Number RONYX27515W

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/18/2021

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 drug eluting stent was implanted in the circumflex (cx).One sprinter balloon was also used during the procedure.Approximately 24 months post procedure the patient suffered from in-stent restenosis and occlusion in the circumflex stent.The event was treated with medical management, risk factor modification and medication.The patient recovered.

• Brand Name: RESOLUTE ONYX OTW
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14235346
• MDR Text Key: 290260740
• Report Number: 9612164-2022-01613
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169602410
• UDI-Public: 00643169602410
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2020
• Device Model Number: RONYX27515W
• Device Catalogue Number: RONYX27515W
• Device Lot Number: 0009081256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2022
• Date Device Manufactured: 04/12/2018
• 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): Other
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White