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

Model Number 26605

Device Problems Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 09/27/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter phone: (b)(6).

Event Description

It was reported that stent damage occurred.The 80% stenosed target lesion was located in the non-tortuous and moderately calcified carotid dissection.An 8.0-29 carotid wallstent was advanced for treatment.However, a high tension was encountered when advancing the stent, then it got kinked and could not be delivered smoothly.The stent was removed from the patient intact, and the procedure was completed with another of same device.There were no patient complications reported, and the patient was stable post-procedure.

Manufacturer Narrative

Initial reporter phone: (b)(6).Device evaluated by mfr.: carotid wallstent monorail 8.0-29 was received for analysis.A visual examination found the stent of the device to be fully deployed from the device.The deployed stent was not returned for analysis.There were no issues identified with the tip of the device.A visual and tactile inspection identified no kinks or damage to the delivery system.

Event Description

It was reported that stent damage occurred.The 80% stenosed target lesion was located in the non-tortuous and moderately calcified carotid dissection.An 8.0-29 carotid wallstent was advanced for treatment.However, a high tension was encountered when advancing the stent, then it got kinked and could not be delivered smoothly.The stent was removed from the patient intact, and the procedure was completed with another of same device.There were no patient complications reported, and the patient was stable post-procedure.

• 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: 17962453
• MDR Text Key: 326322753
• Report Number: 2124215-2023-54146
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0030878957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2023
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 60 KG