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

Model Number 26605

Device Problems Positioning Failure (1158); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2022

Event Type  malfunction  

Manufacturer Narrative

Device eval by mfr: a carotid device was returned for analysis.A visual and tactile examination identified that the device was received with a shaft break in two sections.The shaft break was 170mm proximal from the distal tip.Multiple shaft kinks were identified.The stent was still attached to the detached part of the device and was severely damaged.

Event Description

Reportable based on device analysis completed on 19-jul 2022.It was reported that advancing difficulties and deployment failure occurred.The target lesion was located in the carotid artery.A 8.0-29 carotid wallstent was advanced for treatment.However, during the procedure, the physician had difficulty advancing the device to the lesion and failed to deploy.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed a shaft break and stent 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15193610
• MDR Text Key: 304995797
• Report Number: 2134265-2022-08150
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2022

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: 08/28/2023
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0025278036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2020
• 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: 62 YR
• Patient Weight: 60 KG