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

Model Number 26605

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

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

Event Date 02/05/2024

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.The stenosed target lesion was located in the carotid artery.A 10.0-37 carotid wallstent was advanced for treatment.However, during deployment, the stent would not open smoothly after the microcatheter was withdrawn to 30%.After angiographic observation, the whole stent was returned to the guiding catheter and withdrawn.After removal, it was found that the stent delivery shaft was fractured.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.

Event Description

It was reported that shaft break occurred.The stenosed target lesion was located in the carotid artery.A 10.0-37 carotid wallstent was advanced for treatment.However, during deployment, the stent would not open smoothly after the microcatheter was withdrawn to 30%.After angiographic observation, the whole stent was returned to the guiding catheter and withdrawn.After removal, it was found that the stent delivery shaft was fractured.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.It was further reported that the target lesion was 70% stenosed and was moderately tortuous and mildly calcified carotid artery.

Manufacturer Narrative

Returned product consisted of a carotid wallstent monorail.The device was received with the stent partially deployed on the delivery system.The investigator was unable to deploy the stent due to a complete separation of the outer sheath and severe sheath kinking.A visual and tactile inspection identified a complete break of the outer sheath at more than one location.The sheath of the device was also found to be severely kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.A visual and tactile examination identified no issues with the tip of the device.

Event Description

It was reported that shaft break occurred.The stenosed target lesion was located in the carotid artery.A 10.0-37 carotid wallstent was advanced for treatment.However, during deployment, the stent would not open smoothly after the microcatheter was withdrawn to 30%.After angiographic observation, the whole stent was returned to the guiding catheter and withdrawn.After removal, it was found that the stent delivery shaft was fractured.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.It was further reported that the target lesion was 70% stenosed and was moderately tortuous and mildly calcified carotid artery.

• 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: 18816052
• MDR Text Key: 336654769
• Report Number: 2124215-2024-11720
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• 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: 0031124274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2023
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 70 KG