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

Device Problem Infusion or Flow Problem (2964)

Patient Problems Cardiomyopathy (1764); Thrombosis (2100); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 01/15/2020

Event Type  Death  

Event Description

Stent thrombosis.Hx 13 stents prior plus cardiomyopathy.Coded in cath lab after procedure.Long code resulting hypoperfusion.Safety report id# (b)(4).

• Brand Name: RESOLUTE ONYX STENT
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC VASCULAR
• MDR Report Key: 9693533
• MDR Text Key: 178748542
• Report Number: MW5092881
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/06/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2020
• 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): Death
• Patient Age: 71 YR