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

Model Number 26605

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.:the device was returned with the stent partially deployed by 9mm.Unable to deploy the stent due to an outer break and condition of device of the returned device.A visual and microscopic investigation identified no issues with the tip that could have contributed to the complaint incident.A visual and tactile examination of the device identified that the middle outer was stretched and kinked in multiple locations.The outer detached 28mm distal of the strain relief.The stainless-steel tube handle was also kinked.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 18-feb-2020.It was reported that advancing difficulties were encountered.The target lesion was located in the carotid artery.A 10.0-37 carotid wallstent was selected for use.However, the stent was unable to advance after advancing a part of it.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed stent partial deployment and shaft damage.

• 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: 9786595
• MDR Text Key: 182208883
• Report Number: 2134265-2020-02472
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/04/2020

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: 08/05/2022
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0023287136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2019
• 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: 73 YR
• Patient Weight: 66