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

Model Number	1012631-39
Medical Device Problem Codes	Difficult to Remove (1528); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
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.The additional absolute pro device referenced in b5 is filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a 100% stenosed lesion in the left common iliac artery with heavy calcification and heavy tortuosity.An endarterectomy was performed on the left common femoral artery and an 11fr sheath was placed.A 7x100mm absolute pro self-expanding stent (sess) was advanced to the left external iliac artery and deployed.Then, the 8x39mm omnilink stent delivery system (sds) was brought up to the left common iliac artery, the physician then decided not to deploy the omnilink stent and remove undeployed from the patient.However, during removal the omnilink stent became caught on the absolute pro stent and the stent of the omnilink came off the balloon.The delivery system of the omnilink was removed from the patient; however, the dislodge stent floated through absolute pro stent where it became entangled within the distal portion of the absolute pro.Therefore, physician removed both stents from the patient via a small incision in the endarterectomy patch with a snip tool.There was no adverse patient sequela.A 8x100 absolute pro stent in the left external iliac to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned stent implant.The reported device damaged by another device and difficult to remove could not be tested, as the stent delivery system was not returned for analysis and due to the condition of the returned stent implant.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 similar incidents from this lot.The investigation determined the reported difficulties and surgical intervention appear to be related to circumstances 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: 17154188
• Report Number: 2024168-2023-06446
• Device Sequence Number: 5773063
• Product Code: NIO
• UDI-Device Identifier: 08717648178511
• UDI-Public: 08717648178511
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/19/2023

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 Expiration Date: 04/30/2025
• Device Model Number: 1012631-39
• Device Catalogue Number: 1012631-39
• Device Lot Number: 1111241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2021
• 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: Female
• Patient Weight: 44 KG