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

Model Number	1012631-59
Medical Device Problem Codes	Material Rupture (1546); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified right common iliac artery.The 8.0x59mm omnilink stent delivery system was advanced and when attempting to deploy the balloon on the delivery system ruptured at 6 atmospheres.The stent was under expanded and a 6.0 armada balloon was advanced and used to fully expand the stent.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
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 and without the device to examine, a definitive cause for the reported difficulties could not be determined; however, the subsequent unexpected medical intervention appears to be related to circumstances of the procedure.Factors that may contribute to material ruptures include, but are not limited to, material damage, inflation technique, interactions with other devices, lesion calcification and tortuosity or insufficient preparation prior to use.Difficulty deploying the stent (difficult or delayed activation) may be attributed to several factors including, but are not limited to, stent placement, patient anatomical morphology (calcification, tortuosity), inflation technique during use of the product or undersizing of the vessel.In this case, it is possible that the device may have interacted with the moderately calcified lesion during advancement/positioning, causing the reported material rupture which ultimately contributed to the reported difficult or delayed activation; however, based on the information received and without the device to examine, a conclusive cause cannot be confirmed.The stent was under expanded.A 6.0 armada balloon was advanced and used to fully expand the stent.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.D9 correction: device available for evaluation updated from yes to no.

• 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: 22532825
• Report Number: 2024168-2025-07364
• Device Sequence Number: 7409920
• Product Code: NIO
• UDI-Device Identifier: 08717648178528
• UDI-Public: (01)08717648178528(17)280430(10)4111341
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 08/28/2025

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: 1012631-59
• Device Catalogue Number: 1012631-59
• Device Lot Number: 4111341
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2024
• 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