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

Model Number 26605

Device Problems Break (1069); Positioning Failure (1158)

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

Event Date 04/04/2023

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.The 75% stenosed target lesion was located in the common carotid artery.A 8.0-36 carotid monorail wallstent was advanced for treatment.However, during the release of the stent after reaching the position, it was found that the external sheath was fractured, and the stent could not be deployed.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

Device evaluated by mfr.: carotid wallstent monorail 8.0-36 was received for analysis.The device was received with a complete separation of the inner and outer sheath located at the monorail port of the device.The distal section of the device including a section of inner and outer sheath, the stent, the markerbands and tip of the device were not returned for analysis.No other issues were noted with the returned device.

Event Description

It was reported that shaft break occurred.The 75% stenosed target lesion was located in the common carotid artery.A 8.0-36 carotid monorail wallstent was advanced for treatment.However, during the release of the stent after reaching the position, it was found that the external sheath was fractured, and the stent could not be deployed.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.Upon receiving the device at the manufacturer, the entire distal section had been detached and not returned; however, additional information confirmed that the entire device was removed from the patient.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16864018
• MDR Text Key: 314500748
• Report Number: 2124215-2023-18212
• 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,Followup
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• 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: 0027500775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2021
• 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
• Patient Age: 68 YR
• Patient Weight: 62 KG