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

Model Number 82090-01

Device Problems Entrapment of Device (1212); Difficult to Advance (2920)

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

Event Date 02/23/2021

Event Type  Injury  

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 performed to treat a lesion with mild calcification and no tortuosity in the internal carotid artery.The lesion was long and tight.A nav 6 embolic protection system [eps] bare wire was successfully advanced to the target lesion and the eps filter deployed.An 8.0 x 40 mm xact carotid stent system was advanced to the target lesion with resistance from the anatomy.The stent was successfully deployed; however, on the removal of the stent delivery system, the system could not be removed.Troubleshooting was performed (eg patient coughed, moved to the side), but the system would not move.Angioplasty was performed with two unspecified balloons in an up-and-over technique to allow the delivery system to be removed without further interaction with the stent.The retrieval catheter was then advanced successfully over the bare wire to capture the nav6 filter prior to the bare wire being removed independently with no issues.The stent remains stable in the target lesion.There was no adverse patient sequela.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported difficulty advancing, and entrapment could not be confirmed as it was related to procedural circumstances.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.The investigation determined that the reported difficulty advancing, and entrapment resulting in unexpected medical intervention was likely related to anatomical conditions, as it was reported that resistance was encountered during advancement of the xact carotid stent system due to anatomy.It is possible that the clearance between the guide wire lumen of the xact system and barewire became reduced during advancement causing the device to encounter resistance and become stuck together.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
• MDR Report Key: 11465582
• MDR Text Key: 239391059
• Report Number: 2024168-2021-01943
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010262
• UDI-Public: 08717648010262
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 82090-01
• Device Catalogue Number: 82090-01
• Device Lot Number: 0011561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EMBOSHIELD NAV6 EPS
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 91