MAUDE Adverse Event Report: ABBOTT VASCULAR OMNILINK ELITE BY ABBOTT; STENT, ILIAC

Model Number 1012632-29

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 03/09/2022

Event Type  malfunction  

Event Description

Stent came off of stent balloon in the right common iliac artery and was partially removed using balloon trapping, but was unable to be removed from the left femoral arteriotomy site requiring surgical exploration and foreign body extraction followed by direct repair of the left femoral arteriotomy site with probable perioperative blood loss anemia.Fda safety report id # (b)(4).

• Brand Name: OMNILINK ELITE BY ABBOTT
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 14074344
• MDR Text Key: 289100831
• Report Number: MW5108863
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648178542
• UDI-Public: (01)08717648178542(17)240831(10)
• 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: 04/06/2022

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 Model Number: 1012632-29
• Device Catalogue Number: 1012632-29
• Device Lot Number: 1030941
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 38 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White