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

Model Number RONYX35012UX

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 01/29/2021

Event Type  malfunction  

Event Description

A pt2 coronary guidewire was advanced into the vessel and across the lesion.A 3.0 x 8 mm emerge balloon was advanced and used for predilatation.We then advanced a 3.5 x 12 mm resolute onyx drug-eluting stent.On deployment the stent balloon ruptured at approximately 2 to 3 atm which flared the proximal and distal stent edge but did not fully deployed the stent.

• Brand Name: RESOLUTE ONYX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 11347901
• MDR Text Key: 232541066
• Report Number: 11347901
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RONYX35012UX
• Device Catalogue Number: RONYX35012UX
• Device Lot Number: 0010339532
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2021
• Date Report to Manufacturer: 02/19/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26547 DA