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

Catalog Number 1012633-29

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2023

Event Type  malfunction  

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 325402963
• Report Number: 2024168-2023-11181
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648178580
• UDI-Public: 08717648178580
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1