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

Model Number RONYX30026UX

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

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

Event Date 02/22/2020

Event Type  Injury  

Event Description

The stent came off of the wire in the right coronary artery and migrated to the right common femoral where it was removed from the body.

• Brand Name: MEDTRONIC RESOLUTE ONYX CARDIAC STENT
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC VASCULAR
• MDR Report Key: 9793190
• MDR Text Key: 182521466
• Report Number: MW5093533
• 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: 02/26/2020

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
• Device Expiration Date: 09/22/2021
• Device Model Number: RONYX30026UX
• Device Lot Number: 0009934782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2020
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 83