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

Model Number 26605

Device Problems Positioning Failure (1158); Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/16/2023

Event Type  malfunction  

Manufacturer Narrative

(e1) initial reporter phone: (b)(6).

Event Description

It was reported that foreign material was noted on the device.The 90% stenosed target lesion was located in the non-tortuous and non-calcified internal carotid artery.A 10.0-31 carotid wallstent was advanced for treatment.However, after the device reached the lesion, there was resistance in pushing out the stent.Concerned that the stent might get deformed inside the patient, the device was therefore withdrawn.After the device was removed, a foreign body protruding from the connection point of the delivery shaft and sheath was found.The procedure was completed with a different device.There were no patient complications reported, and patient condition was stable.

Manufacturer Narrative

(e1) initial reporter phone: (b)(6).Device evaluated by mfr.Carotid wallstent monorail was received for analysis.A visual and tactile examination identified a complete separation of the outer sheath of the device located approximately 30mm distal of the main t-valve.Accordion damage was also noted beginning at the sheath separation and extending proximally to the main t-valve.This type of damage is consistent with excessive force being applied to the device when attempting deployment.The device was returned with the stent in the correct position on the delivery system.The investigator was unable to deploy the stent due to a separation of the outer sheath of the device.No evidence of foreign material was identified on or inside the device.

Event Description

It was reported that foreign material was noted on the device.The 90% stenosed target lesion was located in the non-tortuous and non-calcified internal carotid artery.A 10.0-31 carotid wallstent was advanced for treatment.However, after the device reached the lesion, there was resistance in pushing out the stent.Concerned that the stent might get deformed inside the patient, the device was therefore withdrawn.After the device was removed, a foreign body protruding from the connection point of the delivery shaft and sheath was found.The procedure was completed with a different device.There were no patient complications reported, and patient condition was stable.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17175239
• MDR Text Key: 317835218
• Report Number: 2124215-2023-30828
• 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: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• 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: 0030788680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2023
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 55 KG