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

Catalog Number	1012633-29
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during opening of the 10x29mm omnilink balloon expandable stent (bes), the device was removed from the hoop without resistance; however, when the sheath was removed to the tip the stent became dislodged from the balloon.Another omnilink was used to complete the procedure.There was no device use or patient involvement, and there was no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that during opening of the 10x29mm omnilink balloon expandable stent (bes), the device was removed from the hoop without resistance; however, when the sheath was removed to the tip the stent became dislodged from the balloon.Another omnilink was used to complete the procedure.There was no device use or patient involvement, and there was no clinically significant delay in the procedure.No additional information was provided.Subsequent to the initially filed report, the device was received, and the stent was missing.The account stated that the stent was returned with the balloon.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.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 other incidents.The investigation was unable to determine a conclusive cause for the reported stent dislodgement.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: 17913193
• Report Number: 2024168-2023-11181
• Device Sequence Number: 12613754
• Product Code: NIO
• UDI-Device Identifier: 08717648178580
• UDI-Public: 08717648178580
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 11/21/2023

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: 03/31/2026
• Device Catalogue Number: 1012633-29
• Device Lot Number: 2101941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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 Sex: Unknown