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

Model Number 26605

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.A visual examination found that the stent of the device to be mounted in the correct position on the delivery system.The investigator was unable to deploy the stent due to a complete outer shaft break and solidified media inside the delivery system.A visual and tactile inspection identified a complete break of the outer shaft located approximately 160mm proximal of the guidewire port.This type of damage is consistent with excessive tensile 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-dec-2020.It was reported that the stent failed to deploy.The target lesion was located in the internal carotid artery.A 10.0-31 carotid monorail stent self expanding was advanced but failed to deploy.The procedure was completed with a different device.There were no patient complications reported and the patient is stable.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: 11020411
• MDR Text Key: 221824258
• Report Number: 2134265-2020-17975
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2022
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0023924916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2019
• 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: 70 YR
• Patient Weight: 70