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

Model Number	1012632-29
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a tortuous celiac artery lesion with 90% stenosis.A 9x29 mm omnilink elite balloon expanding stent was advanced; however, the device was unable to cross the lesion due to the use of 0.014 inch guide wire.The stent then came off the balloon while attempting to cross the lesion.A snare was used to retrieve the stent and everything was pulled out of the body together.Access was lost and the procedure was aborted.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.It was reported that the omnilink elite stent delivery system (sds) was attempted to be delivered onto a 0.014 inch guide wire.It should be noted that the omnilink elite electronic instructions for use (ifu) specifies to use a 0.035¿ guide wire of appropriate length.In this case, it is unknown if the ifu deviation contributed to the reported event.A conclusive cause for the reported difficulties could not be determined; however, the subsequent unexpected medical intervention appears to be related to the operational context of the procedure.Factors that could contribute to failure to advance include, but are not limited to, patient anatomical morphology, inner lumen obstruction, patient disease state, pre-dilatation strategy, device placement technique, interaction with previously placed stents or accessory devices.Factors that may contribute to stent dislodgment include, but are not limited to, negative pressure during sheath removal, forced sheath removal, mishandling during product preparation for use, interaction with accessory devices, previously placed stents and/or patient disease state.In this case, it is possible that the device may have interacted with the tortuous celiac artery with 90% stenosis during advancement, causing the reported failure to advance.Further interaction with the challenging anatomy during advancement/positioning of the device may have contributed to the reported stent dislodgement; however, this cannot be confirmed.A snare device was used to retrieve the stent, and everything was pulled out of the body together.Access was lost and the procedure was aborted.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.H6: medical device problem code 2017 - failure to follow steps / instructions.

• 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: 25220121
• Report Number: 2024168-2026-02050
• Device Sequence Number: 21276864
• Product Code: NIO
• UDI-Device Identifier: 08717648178542
• UDI-Public: (01)08717648178542(17)281031(10)5052141
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 05/19/2026

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: 1012632-29
• Device Catalogue Number: 1012632-29
• Device Lot Number: 5052141
• 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: 05/08/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2025
• 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 Age: 88 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic