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

Catalog Number	1012630-59
Medical Device Problem Codes	Stretched (1601); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed on (b)(6) 2023, to treat a moderately calcified, mildly tortuous, 60% stenosed lesion in the left common iliac artery.A 7.0mmx59mmx135cm omni elite balloon-expandable stent (bes) was implanted without issue.On (b)(6) 2023, the patient returned for a planned procedure to fix the right sfa.Access was gained from the left side and a non-abbott guide wire was then advanced, but inadvertently and unknowingly went through the stent strut of the previously implanted omni elite stent.Then, a 6f non-abbott sheath was advanced over the guide wire, however, the tip of the sheath became caught on the implanted omni elite stent strut and elongated the implanted stent a large distance in the vessel, however the stent remained implanted.Access was then gained from the right common femoral side, and they went in with a snare device to remove the elongated, implanted stent.When pulling the stent out of the vessel and into a non-abbott sheath for removal from the anatomy, a dissection occurred due to an interaction with the omni elite stent and the vessel wall.Once the dissection was noticed, a non-abbott covered stent was implanted to treat the dissection and re-cover the lesion that the omni elite was removed from.The patient was in stable condition at the end of the procedure.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation determined the reported difficulties and subsequent treatment appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The reported patient effect of dissection is listed in the omnilink elite vascular balloon-expandable stent system, electronic instructions for use as a known patient effect of coronary stenting procedures.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: 17576623
• Report Number: 2024168-2023-08991
• Device Sequence Number: 15520706
• Product Code: NIO
• UDI-Device Identifier: 08717648178481
• UDI-Public: 08717648178481
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 08/18/2023

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 Catalogue Number: 1012630-59
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 6F NON-ABBOTT SHEATH.; NON-ABBOTT GUIDE WIRE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 83 KG