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

Model Number	1012629-19
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right internal iliac artery.A 6fr introducer sheath was advanced beyond the target lesion, then a 6x19mm omni elite balloon expanding stent (bes) was advanced to the target lesion.The introducer sheath was pulled back to deploy the stent; however, prior to attempting to deploy the stent, the physician was not satisfied with the stents position.Therefore, the bes was pulled back into the introducer sheath, but met with resistance with the introducer sheath and the stent of the bes became dislodged and stuck with introducer sheath.The bes and the introducer sheath were able to removed as a single unit.A xience skypoint stent was implanted successfully to complete the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported difficult to remove could not be tested due to the condition of the returned device.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.A conclusive cause for the reported difficulties could not be determined; however, 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.Factors that can contribute to difficult to remove include, but are not limited to, kinks, bends, procedural technique, insufficient support, or interactions with other devices.In this case, it is possible the device may have interacted with accessory devices (introducer sheath) during positioning/retraction, as resistance was noted, causing the observed material deformation, which contributed to the reported difficult to remove, ultimately causing the reported stent dislodgement inside the introducer sheath; however, this cannot be confirmed.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.

• 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: 22674622
• Report Number: 2024168-2025-07911
• Device Sequence Number: 20716307
• Product Code: NIO
• UDI-Device Identifier: 08717648179518
• UDI-Public: (01)08717648179518(17)260331(10)2101941
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 07/31/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: 1012629-19
• Device Catalogue Number: 1012629-19
• Device Lot Number: 2101941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6 FR INTRODUCER SHEATH
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 73 KG