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

Model Number 26665

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the device was received with the stent in the correct place on the delivery system.The stent could not be fully deployed due to a severe kink and complete break in the outer shaft of the device.A visual and tactile inspection identified a complete break of the outer shaft located approximately at the guidewire port.A severe kink on the inner shaft was also identified at the same location.This type of damage is consistent with excessive force being applied to the device.A visual and microscopic examination identified no issues with the tip of the device.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 23jul2020.It was reported that stent deployment failure occurred.A 10x31,5.9f,135cm carotid wallstent was advanced for treatment but failed to deploy.The device was removed and the procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed shaft detached/separated.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10356206
• MDR Text Key: 201377333
• Report Number: 2134265-2020-10334
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08714729781127
• UDI-Public: 08714729781127
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2022
• Device Model Number: 26665
• Device Catalogue Number: 26665
• Device Lot Number: 0022600937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1