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

Model Number	1012631-59
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	05/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a 100% stenosed chronic total occlusion of the left distal common iliac artery with heavy calcification and heavy tortuosity.The 8x59mm omni elite balloon expanding stent (bes) was attempted to be advanced to the target lesion; however, the bes failed to cross due to the anatomy.Therefore, the bes was attempted to be removed from the patient; however, during removal the stent became dislodged from the balloon and remained in the right common femoral artery.The delivery system was removed without issue.A larger opening was made at that interventional access site to advance a hemostat device and remove the stent.The procedure was aborted due to the patient experiencing blood loss, and discomfort which was treated with additional sedation.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the information received, the investigation determined that the reported issue and treatment appears to be related to operational context of the procedure.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The reported patient effect(s) of hemorrhage is listed in the omnilink elite peripheral stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.

• Brand Name: OMNILINK ELITE
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22322842
• Report Number: 2024168-2025-06427
• Device Sequence Number: 8812451
• Product Code: NIO
• UDI-Device Identifier: 08717648178528
• UDI-Public: (01)08717648178528(17)270731(10)4021241
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1012631-59
• Device Catalogue Number: 1012631-59
• Device Lot Number: 4021241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 94 KG