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

Model Number 26605

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 01/12/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 15-feb-2022.It was reported that difficulty loading wire was encountered.The target lesion was located in left carotid artery.A 8.0-29 carotid wallstent monorail stent was advanced for treatment.However, during the procedure, the guidewire could not cross the guidewire lumen of stent delivery shaft.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed tip detachment.

Manufacturer Narrative

Device evaluated by mfr.: carotid wallstent monorail 8.0-29 was received for analysis.This carotid device is recommended for use with a guidewire.During the product analysis the device could not be loaded on to a boston scientific filterwire due to the tip having detached from the device.The guidewire used by the customer was not returned for analysis.A visual and tactile examination identified no issues with the shaft that could potentially have contributed to the complaint incident.The device was returned with the stent fully mounted and over constrained on the device.A visual examination found the tip of the device to have completely detached from the device.This type of damage most probably occurred due to handling of the device and excessive force being applied when re-constraining the device.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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13691176
• MDR Text Key: 286772909
• Report Number: 2134265-2022-01868
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2022

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: 0026530385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2020
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 52 KG