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

Catalog Number 11012-29

Device Problems Stretched (1601); Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Deformation (2976)

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

Event Date 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported stent dislodgement, stretched shaft and material deformation was confirmed.The reported difficult to advance 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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.

Event Description

It was reported that the procedure was to treat a 70% stenosed de novo lesion in the iliac artery with mild calcification and mild tortuosity.An attempt was made to advance the 9.0x29mm otw omni elite stent delivery system (sds); however, it could not be advanced through the 6f sheath.A non-abbott stent was used to complete the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.Returned device analysis found the stent implant was dislocated on the balloon, damaged stent struts, and the distal shaft was stretched.Follow-up with the account confirmed that this damage occurred during removal of the sds from the 6f sheath.No additional information was provided.

• 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: 18115080
• MDR Text Key: 327902330
• Report Number: 2024168-2023-12522
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11012-29
• Device Lot Number: 2052541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2022
• 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