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

Catalog Number 11006-29

Device Problems Stretched (1601); Deformation Due to Compressive Stress (2889)

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

Event Date 08/11/2021

Event Type  malfunction  

Event Description

It was reported the proximal end of the 10x29mm omnilink elite stent delivery system was kinked upon removal of the protective sleeve [hoop coil].The device was not used and another omnilink was used to successfully complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.Per device analysis the shaft was noted to be stretched and the account could not confirm if this occurred during the removal of the device from the packaging or during cleaning of the device; however, the stretched shaft is noted to be kinked at the area of the kink shaft.

Manufacturer Narrative

A visual inspection was performed on the returned device which identified the proximal end of the sds was stretched.The reported deformation due to compressive stress 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 did not indicate a lot specific quality issue.In this case, it is possible that inadvertent mishandling while removing the device from the protective coil (hoop) contributed to the reported deformation due to compressive stress (kinked shaft) and noted stretching/wrinkling of the shaft; however, this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported deformation due to compressive stress.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: 13227594
• MDR Text Key: 283763039
• Report Number: 2024168-2022-00370
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 11006-29
• Device Lot Number: 0022041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2020
• 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