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

Model Number	1012632-29
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 14074344
• Report Number: MW5108863
• Device Sequence Number: 2134682
• Product Code: NIO
• UDI-Device Identifier: 08717648178542
• UDI-Public: (01)08717648178542(17)240831(10)
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 38 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White