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

Model Number 1012623-39

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

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

Event Date 03/14/2022

Event Type  malfunction  

Event Description

It was reported that an omnilink elite stent delivery system was removed from the package.It was noted that the stent had flared struts and was moved/dislocated on the delivery system balloon.The device was not used and there was no patient involvement.No additional information regarding this issue was provided.

Manufacturer Narrative

The device is was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Subsequent to the initial report, additional information was provided.It was reported that the absolute pro vascular stent delivery system was removed from the device packaging and prepared for use.It was noted that the back portion of the stent delivery system was split.The device was not used and there was no patient involvement.No additional information was provided.

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported material deformation was not 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.The investigation was unable to determine a conclusive cause for the reported stent dislodgement and material deformation.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: 14003103
• MDR Text Key: 288595511
• Report Number: 2024168-2022-03546
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648179266
• UDI-Public: 08717648179266
• 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: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 03/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2020
• 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