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

Model Number	1012631-59
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
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 material deformation 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 material deformation include, but are not limited to, inadvertent mishandling during sheath/stylet removal, preparation, during use of the device, or interaction with anatomy or accessory devices.In this case, it is possible that accessory devices may have caused the reported material deformation.An additional omnilink stent was used to cover the damaged section 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 to treat a moderately calcified, mildly tortuous left common iliac artery lesion.An 8x59 mm omnilink elite stent was implanted without issue.The omnilink balloon was then used for post-dilation at a higher atmosphere; however, the distal end of the stent became crushed during advancement of the balloon catheter.An additional omnilink stent was used to cover the damaged section and complete 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: 25219850
• Report Number: 2024168-2026-02048
• Device Sequence Number: 9974045
• Product Code: NIO
• UDI-Device Identifier: 08717648178528
• UDI-Public: (01)08717648178528(17)290131(10)5082141
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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: 1012631-59
• Device Catalogue Number: 1012631-59
• Device Lot Number: 5082141
• 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: 05/05/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 119 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White