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

Model Number 26605

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 01/03/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that there was stent damage.A carotid wallstent monorail 8.0-21 was selected for a carotid stenting procedure.When the stent was removed from the sterile package, a deformation in the mesh structure was noticed.A 0.014 inch guidewire lumen was advanced to about 15-20 centimeters and would not advance further due to the deformation.The stent was removed and replaced with another stent to complete the procedure.There were no patient complications reported.

Event Description

It was reported that there was stent damage.A carotid wallstent monorail 8.0-21 was selected for a carotid stenting procedure.When the stent was removed from the sterile package, a deformation in the mesh structure was noticed.A 0.014 inch guidewire lumen was advanced to about 15-20 centimeters and would not advance further due to the deformation.The stent was removed and replaced with another stent to complete the procedure.There were no patient complications reported.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).Device evaluated by mfr.: carotid wallstent monorail 8.0-21 was returned for analysis.This carotid device is recommended for use with a 0.014 inch (0.36mm) guidewire as per carotid wallstent instructions for use (ifu).During product analysis the investigator was unable to load the device on to a boston scientific 0.014 inch filterwire due to an obstruction inside the guidewire lumen.The guidewire used by the customer was not returned for analysis.A visual and tactile examination found no kinks to the shaft of the device.A guidewire insertion test identified an obstruction inside the guidewire lumen located at the monorail port.This type of damage is consistent with using excessive force when removing the product stylus and handling of the device during preparation which can compromise the patency of the of the inner guidewire lumen and contribute to an obstruction.The device was returned with the stent fully mounted in the correct location on the device.No issues or damage was noted to the wires of the stent.This concludes the product analysis.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 13475328
• MDR Text Key: 285400593
• Report Number: 2134265-2022-01203
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• 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: 0027637057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1