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

Model Number 26606

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.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 75mm distal of the main valve.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

Reportable based on device analysis completed on 03-oct-2020.It was reported that stent failure to deploy were encountered.The 85% stenosed target lesion was located in the severely tortuous common carotid artery.A 10.0-31 carotid wallstent monorail stent was advanced for treatment.However, during deployment, the stent failed to deploy.Severe resistance was felt and unsheath could not be performed.The procedure was completed with another of the same device.There were no patient complications reported and the patient was good.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: 10689699
• MDR Text Key: 211664588
• Report Number: 2134265-2020-14305
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2020

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: 12/08/2023
• Device Model Number: 26606
• Device Catalogue Number: 26606
• Device Lot Number: 0025571555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2020
• Initial Date FDA Received: 10/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2020
• 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
• Patient Age: 60 YR