MAUDE Adverse Event Report: MEDTRONIC, INC. RESOLUTE ONYX; CORONARY DRUG-ELUTING STENT

Model Number RONYX30030UX

Device Problem Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

Event Date 07/10/2020

Event Type  malfunction  

Event Description

Elderly male with history of coronary artery disease, hypertension and chest pain.While having a heart cath procedure, the onyx stent buckled on itself when attempting to place it in the target vessel.Removed without known complications.Procedure was heart cath, left stent percutaneous transluminal coronary angioplasty (ptca).It was successfully removed without known complication.Another 3.0 x 30 onyx stent was deployed in its place.Discharged home the following day.

• Brand Name: RESOLUTE ONYX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC, INC.; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10424870
• MDR Text Key: 203469217
• Report Number: 10424870
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557024
• UDI-Public: (01)00643169557024(17)220226(10)0010155436
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX30030UX
• Device Catalogue Number: (240)RONYX30030UX
• Device Lot Number: 0010155436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30295 DA
• Patient Weight: 80