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

Model Number	1012630-29
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
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 provided, a definitive cause for the reported stent dislodgement and failure to advance could not be determined; however, the subsequent unexpected medical intervention and device embedded in tissue or plaque appears to be related to circumstances of the procedure.Stent dislodgement prior to use may be attributed to several factors including, but not limited to, improper or inadequate crimping at the time of manufacture, incorrect sheath sizing, positive pressure during preparation, forced sheath removal, handling of the stent during preparation, and interaction with accessory devices.Factors that could contribute to failure to advance include, but are not limited to, patient anatomical morphology, patient disease state, pre-dilatation strategy, device placement technique, interaction with previously placed stents or accessory devices.In this case, it is possible the device may have interacted with the 90% stenosed lesion during advancement, as resistance was noted, resulting in the reported failure to advance.Further interaction with the challenging anatomy during retraction of the device may have caused the reported stent dislodgement; however, based on the information provided by the account and without the device to examine, this cannot be confirmed.The stent was crushed in healthy tissue.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.
Event or Problem Description
It was reported that the procedure performed was to treat a subclavian vessel that is 90% stenosed.During advancement of a 7.0x29mm omnilink elite balloon-expandable stent, resistance was met and failed to cross.When attempting to remove the delivery system, the stent dislodged and was crushed in healthy tissue.No other device was used to complete the procedure.There was no adverse patient sequela and no clinically significant delay in procedure.No additional information was provided.

• 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: 21867741
• Report Number: 2024168-2025-04063
• Device Sequence Number: 20775393
• Product Code: NIO
• UDI-Device Identifier: 08717648178467
• UDI-Public: (01)08717648178467(17)270331(10)3100242
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 04/18/2025

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: 1012630-29
• Device Catalogue Number: 1012630-29
• Device Lot Number: 3100242
• 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: 03/28/2025
• Initial Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2023
• 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: Unknown