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

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 12/17/2019

Event Type  malfunction  

Event Description

Stent thrombosis.Fda safety report id# (b)(4).

• Brand Name: RESOLUTE ONYX STENT
• Type of Device: DRUG-ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 9695255
• MDR Text Key: 178961717
• Report Number: MW5092928
• 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
• Was Device Available for Evaluation?: No
• 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): Other
• Patient Age: 80 YR