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

Model Number 26605

Device Problem Material Deformation (2976)

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

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that stent damage occurred.The 70% stenosed target lesion was located in the mildly tortuous segment of left internal carotid artery.An 8.0-29 carotid wallstent was advanced for treatment.However, when the tip was deployed, it was noticed that the stent had burrs.The procedure was completed with another of the device.There were no patient complications nor injuries reported, and the patient condition was stable post-procedure.

Event Description

It was reported that stent damage occurred.The 70% stenosed target lesion was located in the mildly tortuous segment of left internal carotid artery.An 8.0-29 carotid wallstent was advanced for treatment.However, when the tip was deployed, it was noticed that the stent had burrs.The procedure was completed with another of the device.There were no patient complications nor injuries reported, and the patient condition was stable post-procedure.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).Device evaluated by mfr.: a carotid device was received for analysis.A visual and tactile examination identified no issues with the shaft of the device.The device was returned with the stent partially deployed.The stent was noted to be damaged.This concludes the product analysis.

• 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: 17248483
• MDR Text Key: 318344485
• Report Number: 2124215-2023-32745
• 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: 08/08/2023

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: 0029038608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 07/18/2023
• Supplement Dates FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2022
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 65 KG