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

Model Number	1012626-39
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
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 could not be determined; however, the reported material deformation and subsequent unexpected medical intervention appears to be related to circumstances of the procedure.Stent dislodgement 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 patent anatomy or accessory devices.In this case, it is possible the device may have interacted with the anatomy during positioning of the stent, causing the reported stent dislodgement; however, without the device to examine, this cannot be confirmed.A snare was used to pull the stent into the sheath; however, the snare was not able to pull the stent back into the sheath.As a result, the physician had to remove all devices as a single unit including the snare and stent.During the snaring and removal process the stent became mangled, likely causing the reported material deformation.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 was to treat a lesion in the left common iliac artery.The 10x39mm omnilink elite balloon expanding stent (bes) was advanced to the target lesion.When physician pulled back the bes to get better positioning prior to deployment, the stent did not come back with delivery system and became dislodged in the iliac artery.Therefore, a snare was used to pull the stent into the sheath; however, the snare was not able to pull the stent back into the sheath.As a result, the physician had to remove all devices as a single unit including the snare and stent.During the snaring and removal process the stent became mangled.Another same size omnilink bes was used to continue the procedure.There was no adverse patient sequela and no clinically significant delay reported 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: 21997961
• Report Number: 2024168-2025-04892
• Device Sequence Number: 9412358
• Product Code: NIO
• UDI-Device Identifier: 08717648179389
• UDI-Public: (01)08717648179389(17)251031(10)2051241
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2025

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: 10/31/2025
• Device Model Number: 1012626-39
• Device Catalogue Number: 1012626-39
• Device Lot Number: 2051241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown