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

Model Number	1012624-29
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through an article of an individual case regarding a patient presented with a left leg intermittent claudication with severe calcified stenosis of the left common iliac artery (cia) and thrombotic occlusion of the left external iliac artery on (b)(6) 2024.Therefore, thrombectomy was performed and two omnilink elite stents (8.0x29mm / 8.0x39mm) were placed in the cia.Computed tomography (ct) was obtained on postprocedural day 4 because the left ankle-brachial pressure index (abi) remained low at 0.85 compared with 1.07 on the right.Ct revealed the omnilink stents had collapsed within the cia and in-stent stenosis was present.On day 7 balloon angioplasty was performed with additional placement of a non-abbott self-expanding stent.Postprocedural ct confirmed satisfactory stent expansion.However, on (b)(6) 2024, ct obtained for evaluation of gastrointestinal bleeding again showed stent collapse within the cia.Per the physician's opinion the bleeding was not cause by the omnilink stents.Fluoroscopy demonstrated severe stent collapse at the heavily calcified segment.Pre-dilatation was performed with a 7.0 mm non-abbott balloon and a 7.5x60mm supera self-expanding stent was deployed under intention compression to minimize elongation and preserve radial strength.The deployed length was 63 mm (5% elongation).Three-month follow-up ct showed no stent deformation.The patient remained asymptomatic, with the abi increasing to 0.93 on the left.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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 of specific issue.The reported patient effect of stenosis is listed in electronic instructions for use peripheral stent system omnilink elite, ce as a known patient effects of coronary stenting procedures.A conclusive cause for the reported material deformation of the stent and patient effect(s) of stenosis cannot be determined.However, the reported treatments appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional device referenced in b5 is filed under a separate medwatch report number.

• 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: 23662657
• Report Number: 2024168-2025-11788
• Device Sequence Number: 9193025
• Product Code: NIO
• UDI-Device Identifier: 08717648179297
• UDI-Public: (01)08717648179297(17)260331(10)2101843
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 03/31/2026
• Device Model Number: 1012624-29
• Device Catalogue Number: 1012624-29
• Device Lot Number: 2101843
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female