MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID

Model Number 26606

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2020

Event Type  Injury  

Event Description

It was reported that shaft detachment occurred, requiring additional intervention.Vascular access was obtained via right radial artery.The stenosed target lesion was located in the severely tortuous left internal carotid artery.A 8.0-29 carotid wallstent monorail stent was inserted inside a non-bsc guide catheter.However, upon delivery, friction was felt due to highly tortuous artery from the right brachiocephalic artery to the left common carotid artery.The device managed to go through, but the part where the guide wire came out from the monorail lumen was separated and the part where the stent was mounted remained in the body.The remaining part was completely removed using a gooseneck snare along with a non-bsc guide wire.No patient complications were reported post procedure.

Manufacturer Narrative

Device evaluated by mfr: the device was received in two sections as a result of a complete break of the shaft.The device was received with the stent deployed from the delivery system.The stent was not returned for analysis.A visual and tactile inspection identified a complete break of the outer and inner shaft located approximately at the guidewire port.The shaft was also noted to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.A visual and tactile examination identified no issues with the tip of the device.No other issues were identified during the product analysis.

Event Description

It was reported that shaft detachment occurred, requiring additional intervention.Vascular access was obtained via right radial artery.The stenosed target lesion was located in the severely tortuous left internal carotid artery.A 8.0-29 carotid wallstent monorail stent was inserted inside a non-bsc guide catheter.However, upon delivery, friction was felt due to highly tortuous artery from the right brachiocephalic artery to the left common carotid artery.The device managed to go through, but the part where the guide wire came out from the monorail lumen was separated and the part where the stent was mounted remained in the body.The remaining part was completely removed using a gooseneck snare along with a non-bsc guide wire.No patient complications were reported post procedure.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10868160
• MDR Text Key: 217107882
• Report Number: 2134265-2020-16032
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

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: 03/27/2023
• Device Model Number: 26606
• Device Catalogue Number: 26606
• Device Lot Number: 0024499988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 11/26/2020
• Supplement Dates FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDING CATHETER MEDIKIT STIFF J; GUIDING CATHETER MEDIKIT STIFF J; GUIDING CATHETER MEDIKIT STIFF J
• Patient Outcome(s): Required Intervention