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

Catalog Number XRX03008T

Device Problems Stretched (1601); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923); Activation Failure (3270)

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

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.The emboshield nav6 device referenced is filed under separate medwatch report number.

Event Description

It was reported that during an internal carotid artery intervention, a nav 6 embolic protection device (epd) was placed without issue.An xact stent was advanced to the lesion and during deployment, due to the stenosis, the stent elongated, and was accidentally pulled into the sheath.The stent could no longer be released, so the entire stent system, including the stent was removed.Once outside of the patient, the stent remained in the sheath, and was simply removed without issue.Another xact stent was used to complete the procedure.After the procedure and during removal of the epd filter, the filter was not able to be fully retracted into the recovery catheter, so it was removed with the barewire and recovery catheter together.The final results were noted to be good.There was no adverse patient effect or a clinically significant delay in procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported partial deployment, stretched stent and dislodgment were not confirmed as the stent was already fully deployed and 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 complaints.It should be noted that the exact instruction for use states: ¿do not attempt to reposition the delivery system once the stent has made contact with the vessel wall.¿ in this case, the stent elongation appears to be due to the vessel stenosis.Additionally, the physician acknowledged the stent system was inadvertently pulled into the sheath.The investigation determined that the reported difficulties were likely related to circumstances of the procedure.It appears that the stent had elongated due to the vessel stenosis and the system was inadvertently pulled into the sheath preventing further deployment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• 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
• MDR Report Key: 11851720
• MDR Text Key: 252236556
• Report Number: 2024168-2021-04195
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• 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: XRX03008T
• Device Lot Number: 1012561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1