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

Lot Number 0010482712

Device Problem Unraveled Material (1664)

Patient Problem Insufficient Information (4580)

Event Date 04/14/2021

Event Type  malfunction  

Event Description

The stent attempted to be passed through a calcified lesion and partially unraveled.It was removed intact from the patient and a new stent was placed.Fda safety report id# (b)(4).

• Brand Name: RESOLUTE ONYX CARDIAC STENT -DRUG ELUTING
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC VASCULAR
• MDR Report Key: 11737800
• MDR Text Key: 248072109
• Report Number: MW5101037
• Device Sequence Number: 1
• Product Code: NIQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0010482712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR