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

Catalog Number 17508120-60

Device Problems Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Activation Failure (3270); Material Split, Cut or Torn (4008)

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

Event Date 01/02/2024

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a 90% stenosed de novo lesion in the internal carotid artery with mild tortuosity and mild calcification.The 8.0x60mm xpert pro self expanding stent system (sess) was advanced to the target lesion with resistance due to the narrow vessel.Several attempts were made to release the stent from the sheath to deploy the stent; however, the sheath was noted to become bent and split.Therefore, the sess was removed from the patient.There was no adverse patient effect and no clinically significant delay reported in the procedure.Another 8.0x60mm xpert pro stent was used to complete the procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

The device was returned for analysis.The reported difficult to advance was unable to be replicated in a testing environment as it was based on operational circumstances.The reported deformation due to compressive stress/bent sheath and the reported material split, cut or torn/split sheath 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 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 resistance was met with the 90% stenosed, narrow vessel resulting in the reported difficult to advance.During attempted deployment interaction with the 90% stenosed, narrow vessel resulting anatomy resulted in the reported activation failure.Manipulation of the device resulted in the reported bent and split sheath/noted bent shaft/torn outer member and the noted multiple bunched outer member and multiple outer member/inner member kinks; thus contributing to the reported activation failure.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6 medical device problem code: 3270 added.

• 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: 18589009
• MDR Text Key: 334189798
• Report Number: 2024168-2024-01125
• 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: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 17508120-60
• Device Lot Number: 2050361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2022
• 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: WORKHORSE GUIDEWIRE