MAUDE Adverse Event Report: ABBOTT VASCULAR XACT CAROTID STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number 82090-01

Device Problems Loose or Intermittent Connection (1371); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Material Deformation (2976); Material Split, Cut or Torn (4008)

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

Event Date 12/09/2021

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2021, a percutaneous intervention was performed on the left internal carotid, mildly calcified lesion.A barewire and 90cm cook shuttle sheath were placed without issues.Following, an xact stent delivery system (sds) advanced into position, across the lesion.As protocol, negative was applied to the sheath when air was observed retracting into the syringe.As prevention, additional aspiration was performed.The xact sds was removed, and the physician tightened the tuohy borst over the 014 wire.Following, no more air was observed in the syringe when aspiration was applied without the xact sds.The physician was concerned that the xact sds had a kink, tear, or the shaft was not perfectly round, or the connection between the xact shaft and tuohy borst was allowing air to retract into the syringe, causing the air retraction when negative was applied.A tear or kink were not observed.The same xact was re-inserted onto the same barewire when unusual resistance/stickiness was felt during advancement, reportedly this was due to drying blood inside the xact lumen.The xact was flushed, and no additional stickiness was noted following.Additional aspiration with negative was not applied the second time the xact sds was advanced.The xact stent had been successfully implanted.No air was observed in the anatomy.There was no adverse patient sequela and there was no clinically significant delay (no clinical symptoms).No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned device.The reported difficulty advancing, material deformation, material split, cut or torn and loose connections were not confirmed.There were no kinks, tears, material deformation or shaft damage noted on the returned device.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 complaints.It was reported that after the first insertion of the xact system, difficulties were encountered during aspiration, so the xact was removed and then reinserted a second time.The procedure was completed with the xact stent successfully implanted.It should be noted that the xact carotid stent system instruction for use (ifu) states: ¿carefully inspect device components prior to use to verify that they have not been damaged and that the size, shape and condition are suitable for the procedure for which they are to be used.A device or access device which is kinked or damaged in any way should not be used.If pouch is damaged do not use.¿ in this case, reinsertion of the device does not appear to have contributed the difficulties.The investigation was unable to determine a cause for the reported difficulties.Based on the reported information and evaluation of the returned product, the reported difficulty advancing the barewire was the result of drying blood inside the xact lumen.A definitive cause for the difficulty observed when aspiration was performed could not be determined.It may be possible that the syringe was not properly connected to the sheath during aspiration or the sheath itself was damaged; however, this could not be confirmed.The unexpected medical intervention was due to case circumstances.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: XACT CAROTID 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: 13029268
• MDR Text Key: 287563529
• Report Number: 2024168-2021-11815
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010262
• UDI-Public: 08717648010262
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040038
• 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: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 82090-01
• Device Catalogue Number: 82090-01
• Device Lot Number: 0121761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2020
• 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
• Treatment: 90CM COOK SHUTTLE SHEATH; BAREWIRE
• Patient Outcome(s): Required Intervention