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

Lot Number 0009793102

Device Problem Peeled/Delaminated (1454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2019

Event Type  Injury  

Event Description

Stent stripped off balloon while advancing to lesion in coronary artery.Fda safety report id# (b)(4).

• Brand Name: RESOLUTE ONYX
• Type of Device: CORONARY DRUG - ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND
• MDR Report Key: 9134687
• MDR Text Key: 160580340
• Report Number: MW5090094
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0009793102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR