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

Catalog Number 17508120-40

Device Problems Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)

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

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The xpert pro device is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

It was reported that the procedure was to treat an internal carotid artery lesion.A 6mmx40mm xpert pro self-expanding stent system (ses) was advanced to the target lesion through a 6f catheter.After loosening the knob, the sheath was slowly withdrawn [deployment], however, due to resistance with anatomy, the stent only partially deployed from the delivery system; therefore the procedure was completed with another xpert ses.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported activation 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.Reportedly, the xpert pro device was used in the internal carotid artery.It should be noted the xpert pro instructions for use states: the xpert pro peripheral self-expanding stent system is intended for use in peripheral vasculature or the biliary duct.The deviation of the instructions for use appears to have caused/contributed to the reported difficulties.Additionally, the expiration date on the specific product labels could not be confirmed.However, a review of the labels attached to the electronic lot history record for this lot was conducted and all labels indicated an expiration date (use by date) of 6/30/2023.However, the device was used on 1/25/2024.There were no adverse patient effects and no clinically significant delay in the procedure.The expiration date of the product is important for sterility, efficacy, and performance of the device.Per the xpert pro sess risk assessment.Potentially adverse events of using the device post expiration date include infection and hypersensitivity.However, in this case there was no reported patient adverse events reported.It should be noted the xpert pro instructions for use states: use prior to the ¿use by¿ date.The deviation of the instructions for use does not appear to have caused/contributed to the reported difficulties.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 deviation of the instructions for use and subsequent circumstances of the procedure as it is likely that the device was bent in the internal carotid artery resulting in preventing the shaft lumens from moving freely.Interaction/manipulation of the device resulted in the noted kinked inner member and noted bent shaft further preventing the shaft lumens from moving freely.Manipulation of the compromised device during attempted stent deployment resulted in the noted stent strut lifted/bent and protruding through the noted torn outer member; thus resulting in the reported activation/deployment failure.Further manipulation of the compromised device and/or handling during shipment for return analysis likely resulted in the noted device damages (bent tip, separated/broken stent struts, outer member bent/torn/separated in multiple locations, bent strain relief).There is no indication of a product quality issue with respect to manufacture, design or labeling.B5 - describe event or problem: updated.D4 - lot number updated from 3060161 to 1072061.H6: device code 2017 added.

Event Description

Subsequent to the initially filed report, additional information was received that confirmed the complaint device was a 8.0x40mm xpert pro and the device was used past the expiration date.No additional information was provided.

• 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: 18669808
• MDR Text Key: 335187918
• Report Number: 2024168-2024-01606
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 17508120-40
• Device Lot Number: 1072061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2021
• 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: 6F GUIDING CATHETER.