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

Catalog Number 11011-29

Device Problems Difficult to Advance (2920); Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 09/14/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat an 80% stenosed lesion in the subclavian artery with heavy tortuosity.Resistance was met while advancing the 8x29mm omnilink elite stent delivery system (sds) through the sheath, so the sds was removed and the balloon was observed to be torn and bent.There was no adverse patient effect and no clinically significant delay reported.Another same size sds was used to complete the procedure.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

Subsequent to the initial report, the following information was reported: it was reported that the device was not soaked prior to use.After removal of the device from the patient, the stent was removed from the stent delivery system (sds), intentionally, to inspect the balloon.The stent was discarded.No additional information was provided.

Manufacturer Narrative

A visual and functional inspection was performed on the returned device.The reported material split, cut or torn was confirmed.The reported difficult to advance could not be tested due to the condition of the returned device.The reported material deformation could not be tested, as the component was not returned.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 difficult to advance/position and material deformation; however, the reported split, cut, or torn material appears to be related to circumstances of the procedure.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: 15533993
• MDR Text Key: 302056364
• Report Number: 2024168-2022-10264
• 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,Followup
• Report Date: 12/02/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 11011-29
• Device Lot Number: 2011141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/03/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2022
• 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