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 04/30/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the device was received with the stent partially deployed from the delivery system.The stent could not be fully deployed due to a break in the outer shaft of the device and the presence of solidified media within the device.A visual and tactile inspection identified a complete break of the shaft located approximately 28mm distal of the main valve of the device.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 10-jun-2020.It was reported that the stent failed to deploy.The target lesion was located in the internal carotid artery to common carotid artery.A 10.0-31 carotid wallstent monorail stent was advanced for treatment.However, during deployment, the outer sheath could not be pulled due to resistance and the stent could not be deployed.A non-bsc guide catheter was advanced to retrieve the device and the procedure was completed with another of the same device.No patient complications reported and the patient was good.However, returned device analysis revealed a 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: 10168050
• MDR Text Key: 195570636
• Report Number: 2134265-2020-08146
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2023
• Device Model Number: 26606
• Device Catalogue Number: 26606
• Device Lot Number: 0025333035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2020
• 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