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

Model Number 26605

Device Problems Difficult to Insert (1316); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 01/28/2024

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The patient presented with dissection and underwent stenting.The target lesion was located in the right carotid artery.A 6.0-22 carotid wallstent was advanced for treatment.However, during the procedure, the stent could not be pushed into the long sheath.After removal, it was noted that the stent was deformed.The procedure was completed with another of same device.There were no complications reported and the patient was stable post procedure.

Manufacturer Narrative

H6 - device code: updated from material deformation to material integrity problem.Carotid wallstent monorail 6.0-22 was received for analysis.The device is compatible with a 5fr sheath however, the customer's 5fr introducer sheath was not returned for analysis.The investigator successfully advanced the device through a boston scientific 5fr sheath and successfully withdrew it with no resistance experienced.The device was returned with the stent fully deployed from the delivery system.The deployed stent was not returned for analysis.A visual and tactile examination found no damage or issues with the delivery system of the device.No other issues were identified during the product analysis.

Event Description

It was reported that stent damage occurred.The patient presented with dissection and underwent stenting.The target lesion was located in the right carotid artery.A 6.0-22 carotid wallstent was advanced for treatment.However, during the procedure, the stent could not be pushed into the long sheath.After removal, it was noted that the stent was deformed.The procedure was completed with another of same device.There were no complications reported and the patient was stable post procedure.It was further reported that the lesion was 50% stenosed, mildly tortuous and non-calcified.The stent delivery system was deformed.

Manufacturer Narrative

H6 - device code: updated from material deformation to material integrity problem.

Event Description

It was reported that stent damage occurred.The patient presented with dissection and underwent stenting.The target lesion was located in the right carotid artery.A 6.0-22 carotid wallstent was advanced for treatment.However, during the procedure, the stent could not be pushed into the long sheath.After removal, it was noted that the stent was deformed.The procedure was completed with another of same device.There were no complications reported and the patient was stable post procedure.It was further reported that the lesion was 50% stenosed, mildly tortuous and non-calcified.The stent delivery system was deformed.

• 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: 18658073
• MDR Text Key: 334737862
• Report Number: 2124215-2024-06822
• 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,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• 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: 0031313416
• 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?: Yes
• Date Device Manufactured: 03/27/2023
• 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: 61 YR
• Patient Weight: 65 KG