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

Model Number 26605

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that shaft fracture occurred.The 91% stenosed target lesion was located in a mildly tortuous and mildly calcified vessel in the neck.A 10.0-37 carotid wallstent was advanced to treat the lesion.However, during procedure, the shaft was fractured.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.

Event Description

It was reported that shaft fracture occurred.The 91% stenosed target lesion was located in a mildy tortuous and mildly calcified vessel in the neck.A 10.0-37 carotid wallstent was advanced to treat the lesion.However, during procedure, the shaft was fractured.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.The device was received with the stent partially deployed from the delivery system.The stent could not be deployed due to a complete break in the outer shaft of the device and solidified media inside the delivery system.A visual and tactile inspection identified a complete break of the outer shaft located approximately at the guidewire port.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.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).Device evaluated by mfr: the device was received with the stent partially deployed from the delivery system.The stent could not be deployed due to a complete break in the outer shaft of the device and solidified media inside the delivery system.A visual and tactile inspection identified a complete break of the outer shaft located approximately at the guidewire port.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.

• 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: 10941771
• MDR Text Key: 219505327
• Report Number: 2134265-2020-16801
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2023
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0024600409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 68