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

Model Number 26605

Device Problems Positioning Failure (1158); Mechanical Problem (1384); Defective Device (2588); Difficult to Advance (2920)

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

Event Date 04/28/2022

Event Type  malfunction  

Event Description

It was reported that the stent was not fully resconstrained.The 80% stenosed target lesion was located in the moderately tortuous and mildy calcified common carotid artery.A 10.0-24 carotid wallstent was advanced for treatment.However, the stent was unable to release.When the stent was about to remove, it was not fully reconstrained.The device was removed carefully and slowly.Another carotid wallstent monorail 10.0-24 was deployed but still the sent was unable to release and it was not fully resconstrained prior to removal.The device was also removed carefully and slowly, and it seems that the device was damaged.The procedure was completed with another of same device.No patient complications were reported and the patient was stable.

Manufacturer Narrative

B5.Describe event or problem- updated.

Event Description

It was reported that the stent was not fully reconstrained.The 80% stenosed target lesion was located in the moderately tortuous and mildy calcified common carotid artery.A 10.0-24 carotid wallstent was advanced for treatment.However, the stent was unable to release.When the stent was about to remove, it was not fully reconstrained.The device was removed carefully and slowly.Another carotid wallstent monorail 10.0-24 was deployed but still the stent was unable to release and it was not fully reconstrained prior to removal.The device was also removed carefully and slowly, and it seems that the device was damaged.The procedure was completed with another of same device.No patient complications were reported and the patient was stable.It was further reported that the target lesion was not calcified and the stents were deployed by following the normal operation steps.

• 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: 14521707
• MDR Text Key: 292796317
• Report Number: 2134265-2022-05903
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0026692928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• 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