MAUDE Adverse Event Report: ABBOTT VASCULAR OMNILINK ELITE PERIPHERAL STENT SYSTEM; PERIPHERAL STENT DELIVERY SYSTEM

Catalog Number	1012632-19
Medical Device Problem Codes	Off-Label Use (1494); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the procedure was to treat a stenosed lesion in the brachiocephalic artery.After the lesion was pre-dilated with a non-abbott balloon catheter, the 9.0x19mm omnilink elite stent delivery system (sds) was inflated to 11 atmospheres (atm) for 10 seconds.When the sds was attempted to be removed, the stent migrated proximal to the target lesion.A non-abbott balloon catheter was used to over dilate the migrated stent to complete the procedure.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.It was reported the procedure was to treat a stenosed lesion in the brachiocephalic artery.It should be noted that the omnilink elite instructions for use (ifu) states: the omnilink elite stent system is indicated for the treatment of atherosclerotic iliac artery lesions.It is unknown the ifu deviation contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported stent migration.The reported treatment and foreign body in patient appear to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Common Device Name: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18806185
• Report Number: 2024168-2024-02559
• Device Sequence Number: 7248866
• Product Code: NIO
• UDI-Device Identifier: 08717648178535
• UDI-Public: 08717648178535
• 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
• Report Date (Section B): 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 1012632-19
• Device Lot Number: 2070741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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: TERUMO'S RADIFORCUS 0.035INCH 260CM; TOKAI MEDICAL PRODUCTS' OPTIMO 8F 90CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown