MAUDE Adverse Event Report: ABBOTT VASCULAR XPERT PRO SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 17504135-40

Device Problems Difficult to Advance (2920); Activation Failure (3270)

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

Event Date 06/20/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was to treat a de novo, 80% stenosed, mildly calcified and moderately tortuous vessel in the hepatic artery.The 4.0x40mm xpert pro self-expanding stent system (sess) had resistance with the guide wire during advancement.The delivery system reached the lesion, however, it was difficult to release the stent and just partially deployed.Only part of the stent was released and the stent did not adhere to the vessel wall.The stent and the delivery system were removed from the anatomy.There was no problem in the deployment mechanism.Another same size non-abbott device was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported difficult to advance was able to be confirmed.The reported activation/deployment failure was able to be 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 from this lot.As there was no reported damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the 80% stenosed, mildly calcified and moderately tortuous anatomy and/or inadvertent mishandling resulted in the noted device damages (outer member wrinkled/ kinked in multiple locations, distal end of the outer member indented proximally) thus resulting in the reported difficult to advance and the reported activation/deployment failure.Interaction/manipulation of the device resulted in the exposed struts appearing twisted and deformed after attempted stent deployment.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XPERT PRO SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14958510
• MDR Text Key: 295900565
• Report Number: 2024168-2022-07379
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K050534
• 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: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 17504135-40
• Device Lot Number: 2010561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2022
• 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
• Treatment: BOSTON SCIENTIFIC V18 CONTROL WIRE,300CM