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

Model Number	1012624-39
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	06/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the procedure was to treat a moderately calcified lesion in the right common iliac artery.The 8.0x39mm otw omnilink elite stent delivery system (sds) was advanced to the target lesion; however during inflation, the balloon ruptured at nominal pressure.The sds was removed and a non-abbott balloon catheter was used to fully appose the stent to the vessel wall.There were no adverse patient effects and no clinically significant delay in the procedure.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.Based on the information provided, 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 under-sizing 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 sds was removed, and a non-abbott balloon catheter was used to fully appose the stent to the vessel wall.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.

• 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: 22318778
• Report Number: 2024168-2025-06417
• Device Sequence Number: 21088551
• Product Code: NIO
• UDI-Device Identifier: 08717648179303
• UDI-Public: (01)08717648179303(17)280430(10)4111841
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/24/2025

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: 4111841
• 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: 06/16/2025
• Initial Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• 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