MAUDE Adverse Event Report: AV-TEMECULA-CT XACT CAROTID STENT SYSTEM

Catalog Number 82092-01

Device Problems Break (1069); Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: sheath: cook shuttle, embolic protection: emboshield nav6.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 referenced is being filed under a separate medwatch report.

Event Description

This was a procedure to treat the left internal carotid artery.There was no challenging anatomy.An xact carotid stent delivery system (sds) was advanced and the stent was successfully deployed.During removal of the sds, there was no resistance noted by the physician; however, it looked on angio like the sds may have hit a strut on the distal edge of the stent.The sds was able to be removed easily through the implanted stent.When the sds reached the sheath, there was significant resistance noted.The physician noted that the sds inside the sheath felt "weird" and there was a lot of tightness.It was attempted to manipulate the sds out of the sheath, but it was noted that the resistance was only getting worse and force was being used.The sheath was pulled back a little and it seemed like the inner parts of the sds were unraveling and the nose cone looked separated.The wiring of the sds now appeared to be wound around the nav6 wire and it was attempted to cut the sds to try and remove it from the sheath.After the sds was cut, they tried to remove it, but it seemed like more and more wire was coming out and the sds was not coming out.It was then decided that the filter of the emboshield nav6 needed to be removed as it was still deployed.The physician was unable to use the recovery catheter to retrieve the filter as the sds was wound around the bare wire, so it was attempted to move the sheath up to pull out the filter.The filter was still deployed but was able to be removed and the patient is fine.Everything else was then removed as a single unit and nothing was left in the patient.The left groin was then accessed with a 5fr sheath to view the stent and the area and everything looked great.There were no adverse patient sequela and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The reported shaft break, tip separation and difficult to remove the guide wire were unable to be confirmed.The reported difficulty to remove from an introducer sheath (is) was unable to be confirmed due to the returned condition of the self expanding stent system (sess) and is.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The investigation determined the reported difficulties to appears to be related to operational circumstances of the procedure.Based on the returned analysis and photos, it is likely that during the procedure the inner layer of the introducer sheath became damaged and separated causing the inner braiding/coil in the is to unravel on the sess resulting in the difficulty to remove from the is and guide wire.Additional manipulation during retraction against resistance likely resulted in the inner braiding/coils of the is to separate and causing the appearance of the shaft break and tip separation.It should be noted that the section that was cut during the procedure was likely the stretched braided coil of the is.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: XACT CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8696476
• MDR Text Key: 147997685
• Report Number: 2024168-2019-04673
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 82092-01
• Device Lot Number: 8040261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR