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

Model Number	1012631-59
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left subclavian artery with mild tortuosity and heavy calcification.The 8.0x59mm otw omni elite balloon expandable stent system (bess) was advanced to the lesion; however, it was noted that the stent was not on the delivery system.The bess was removed from the patient anatomy.The target lesion was imaged, and it was noted that the stent had dislodged and was at the tip of the introducer sheath.The introducer sheath was removed with the dislodged stent.There was not resistance met during advancement.Another 8x29mm otw omni elite stent was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned stent.The reported stent dislodgement was confirmed.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.A conclusive cause for the reported stent dislodgement could not be determined.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: 16725848
• Report Number: 2024168-2023-03740
• Device Sequence Number: 8171866
• Product Code: NIO
• UDI-Device Identifier: 08717648178528
• UDI-Public: 08717648178528
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/26/2023

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: 05/31/2025
• Device Model Number: 1012631-59
• Device Catalogue Number: 1012631-59
• Device Lot Number: 1120241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 104 KG