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

Model Number	1012631-29
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left common iliac artery with 70% stenosis.The 8.0x29mm omnilink elite stent delivery system (sds) was advanced over a.035 guidewire through a standard 6 french (fr) sheath, utilizing the left anterior tibial for access.As the distal end of the sds was advanced to the proximal portion of the left anterior tibial, it would not advance through the severe calcification.The device was then attempted to be removed but got caught on the distal end of the sheath.The sds and the sheath were removed as a unit.Wire access was maintained as the catheter and sheath were successfully removed.There was no adverse patient effect and there was no clinically significant delay in the procedure.The procedure was terminated and no other intervention was attempted for the iliac lesion.No additional information was provided.
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left common iliac artery with 70% stenosis.The 8.0x29mm omnilink elite stent delivery system (sds) was advanced over a.035 guidewire through a standard 6 french (fr) sheath, utilizing the left anterior tibial for access.As the distal end of the sds was advanced to the proximal portion of the left anterior tibial, it would not advance through the severe calcification.The device was then attempted to be removed but got caught on the distal end of the sheath.The sds and the sheath were removed as a unit.Wire access was maintained as the catheter and sheath were successfully removed.There was no adverse patient effect and there was no clinically significant delay in the procedure.The procedure was terminated and no other intervention was attempted for the iliac lesion.Returned device analysis identified the stent implant was stationary on the balloon, but not between the markers.The account confirmed there was stent dislodgement.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported failure to advance could not be evaluated as the exact anatomical conditions encountered by the device used during the procedure could not be replicated in the test laboratory.The reported difficult to remove could not be tested due to the condition of the returned device.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.The investigation determined the reported difficulties 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: 15615579
• Report Number: 2024168-2022-10680
• Device Sequence Number: 5873595
• Product Code: NIO
• UDI-Device Identifier: 08717648178504
• UDI-Public: 08717648178504
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 10/25/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: 1012631-29
• Device Catalogue Number: 1012631-29
• Device Lot Number: 1030941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0.035 GUIDE WIRE; 6FR SHEATH
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 86 KG