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

Catalog Number ONYXNG35015UX

Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/21/2023

Event Type  Injury  

Event Description

Physician attempted to advance a stent to a lesion in the distal rca(right coronary artery).They were unable to advance the stent past the lesion.They pulled the stent back to remove it and it came off the balloon.The stent remained on the wire.They then pulled the wire back to the aorta with the stent on the wire but was unable to remove from body.The physician upgraded sheath and entered a second wire, then inflated a balloon past the stent and was able to pull the stent out successfully.Everything was removed from body.Sheath was removed and a closure device was applied.

• Brand Name: ONYX FRONTIER RESOLUTE FRONTIER STENT
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND
• MDR Report Key: 16446935
• MDR Text Key: 310369596
• Report Number: MW5115246
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/22/2023

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 Catalogue Number: ONYXNG35015UX
• Device Lot Number: 0011412935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON; GUIDEWIRE; SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White