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

Model Number	1012626-39
Medical Device Problem Codes	Material Rupture (1546); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/22/2025
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.A conclusive cause for the reported material rupture and patient effects could not be determined.However, the subsequent treatment appears to be related to the procedural context.Potential factors that may contribute to balloon material rupture include, but not limited to, balloon damage during processing of the balloon material, materials, inflation technique, and interactions with other devices, lesion calcification, or insufficient preparation prior to use.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported material rupture.Additionally, it is possible that the reported material rupture contributed to the reported difficult or delayed activation.The reported patient effect of dissection is listed in the omnilink elite instructions for use of coronary stenting procedures.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.The additional device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a common iliac artery.A non-abbott guide wire and guide catheter were advanced to the external iliac artery on the right and significant stenosis was present in the common femoral artery therefore, the wire was exchanged to a.018 command guide wire.Laser atherectomy was preformed 3 times with angio showing significant improvement flow.A 10x39mm omnilink elite stent was advanced over the wire into the distal aorta and deployed; however, the balloon on the delivery system ruptured at 6 atmospheres not allowing the stent to fully expand.A 12x40mm armada 35 balloon dilatation catheter was attempted to be used for post dilatation: however, ruptured at 6 atmospheres.(bdc).During removal resistance was felt when pulling into the sheath and the bdc separated in half and the distal marker still on the wire just outside the sheath.An attempt was made to pull in the separated portion into the sheath when aspirating; however, was unsuccessful as the balloon continued to get stuck on the arterial wall.A hemostat was used to pull the separated portion of the balloon from the arteriotomy all separated portions were removed.A perclose was used in attempt to close the left femoral artery; however, the artery was enlarged; therefore, direct pressure was held and access to the contralateral right side was gained.Angio revealed significant extravasation of contrast and a 10x5 non-abbott stent was implanted, post dilatated with 9x40mm unspecified balloon.However, angiogram showed some slight continued extravasation and a 8x39 non-abbott was implanted and post dilatated with a 9x40mm unspecified balloon.The right femoral arteriotomy was closed with a perclose device.There was no adverse patient sequela and clinically significant delay was noted.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: 22338932
• Report Number: 2024168-2025-06552
• Device Sequence Number: 9060819
• Product Code: NIO
• UDI-Device Identifier: 08717648179389
• UDI-Public: (01)08717648179389(17)260430(10)2111741
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/26/2025

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: 04/30/2026
• Device Model Number: 1012626-39
• Device Catalogue Number: 1012626-39
• Device Lot Number: 2111741
• 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: 06/03/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: .018 COMMAND GUIDE WIRE.; 12X40MM ARMADA 35 BALLOON.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 123 KG