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

Model Number	1012624-39
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	07/25/2025
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.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, and interaction with patent anatomy or 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 moderately calcified, 75-80% stenosed lesion during advancement, as resistance was noted, causing the reported failure to advance.Further interaction with the challenging anatomy may have contributed to the reported stent dislodgement; however, without the device to examine, this cannot be confirmed.A balloon was used to push the dislodged stent all the way to the bifurcation and partially implanted in the target lesion.Another non-abbott stent was used to completely cover the target lesion and complete the procedure.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 performed in the right common iliac artery with 75-80% stenosis and moderate calcification.The 8.0x39mm omnilink elite peripheral stent system was being advanced when resistance was noted due to the anatomy and the stent came off the balloon in the aortic bifurcation.A balloon was used to push the dislodged stent all the way to the bifurcation and partially implanted in the target lesion.Another non-abbott stent was used to completely cover the target lesion and complete the procedure.There was no adverse patient sequelae.Although there was a slight delay in the procedure, there was no patient harm; therefore, the delay was not significant.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: 22843013
• Report Number: 2024168-2025-08712
• Device Sequence Number: 4849016
• Product Code: NIO
• UDI-Device Identifier: 08717648179303
• UDI-Public: (01)08717648179303(17)261031(10)3051541
• 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
• Device Implanted Year: 2025
• 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): 08/19/2025

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: 1012624-39
• Device Catalogue Number: 1012624-39
• Device Lot Number: 3051541
• 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: 07/25/2025
• Initial Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2023
• 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