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

Model Number	1012623-39
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
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 the procedure was to treat a dissection in the right common iliac artery.The 7.0 x 39 mm x 80 cm omnilink stent failed to cross due to the anatomy.During removal, resistance was felt with the introducer sheath, the stent struts stretched, and the stent moved but remained on the balloon.A new omnilink stent was implanted without further issue.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the return device.The reported failure to advance and difficulty removing were not confirmed as it was related to procedural conditions.The stent damage and dislodgment were 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 other incidents and/or complaints reported from this lot.Based on the information provided, the reported difficulties appear to be due to circumstances of the procedure.It is likely that the reported failure to advance was due to interaction with the anatomy.Additionally, after the failed attempt to cross, it is likely that the stent became compromised on the balloon such that during removal, the stent caught on the distal end of the introducer sheath causing further damage to the stent and the stent to dislodge from the original crimped location on the balloon.There is no indication of a product 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
• MDR Report Key: 11631713
• Report Number: 2024168-2021-02880
• Device Sequence Number: 2935423
• Product Code: NIO
• UDI-Device Identifier: 08717648179266
• UDI-Public: 08717648179266
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 01/31/2024
• Device Model Number: 1012623-39
• Device Catalogue Number: 1012623-39
• Device Lot Number: 0082741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 50