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

Model Number	26265
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2124215-2023-05172
• Device Sequence Number: 5704258
• Product Code: JCT
• UDI-Device Identifier: 08714729406464
• UDI-Public: 08714729406464
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female