MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT RP ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number 26265

Device Problem Break (1069)

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

Event Date 12/16/2022

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.The patient underwent post transjugular intrahepatic portosystemic shunt for the treatment of large volume clot in the main extrahepatic portal superior mesenteric vein and splenic confluence extending into the right portal vein.A 10x42x135/ 7f reduced profile wallstent rp endoprosthesis was selected to treat the lesion.However, the device was found to be broken proximal to the hub.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: 10x42x135/ 7f unistep plus was received for analysis.The device was returned with the stent in the correct position on the delivery system.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile inspection found the shaft of the device to be separated at approximately 23mm distal of the main t-valve.This type of damage is consistent with excessive force being applied excessive force to the delivery system.

Event Description

It was reported that shaft break occurred.The patient underwent post transjugular intrahepatic portosystemic shunt for the treatment of large volume clot in the main extrahepatic portal superior mesenteric vein and splenic confluence extending into the right portal vein.A 10x42x135/ 7f reduced profile wallstent rp endoprosthesis was selected to treat the lesion.However, the device was found to be broken proximal to the hub.There were no patient complications reported.

• Brand Name: WALLSTENT RP ENDOPROSTHESIS
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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: 16404935
• MDR Text Key: 309871013
• Report Number: 2124215-2023-05172
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 08714729406464
• UDI-Public: 08714729406464
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2023
• Device Model Number: 26265
• Device Catalogue Number: 26265
• Device Lot Number: 0028231577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• 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: 65 YR
• Patient Sex: Female