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

Model Number	1012624-19
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
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 failure to advance and stent dislodgement could not be determined; however, the subsequent unexpected medical intervention appears to be related to circumstances of the procedure.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.Stent dislodgement may be attributed to several factors including, but not limited to, positive pressure during preparation, forced sheath removal, handling of the stent during preparation, interaction with patent anatomy or accessory devices.In this case, it is possible the device may have interacted with the heavily calcified, heavily tortuous lesion during advancement, causing the reported failure to advance.Further interaction with the challenging anatomy during advancement/retraction of the device may have contributed to the reported stent dislodgement; however, this cannot be confirmed.The stent delivery system was withdrawn, and a snare device was used to retrieve the dislodged stent.Based on the results of the complaint investigation, there is no indication of a product quality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 the procedure was to treat a heavily calcified and tortuous lesion in the iliac artery.The 8.0x19mm otw omnilink elite stent delivery system (sds) was advanced however the during the attempt to cross the lesion the stent dislodged.The sds was withdrawn and a snare device was used to retrieve the dislodged stent.The procedure was completed using a same size device.There were no adverse patient effects and no clinically significant delay in the 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: 23878641
• Report Number: 2024168-2025-12228
• Device Sequence Number: 15858672
• Product Code: NIO
• UDI-Device Identifier: 08717648179280
• UDI-Public: (01)08717648179280(17)260930(10)3041141
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

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 Expiration Date: 09/30/2026
• Device Model Number: 1012624-19
• Device Catalogue Number: 1012624-19
• Device Lot Number: 3041141
• 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: 12/15/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2023
• 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