MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	26280
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1- initial reporter address 1: (b)(6).E1- initial reporter phone: (b)(6).
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the superior vena cava.After lesion preparation, a 12x90/8fr uni plus halo 75cm wallstent endoprosthesis was selected for use.However, prior to implanting, it was found that the stent was fractured.In order to avoid adverse events after implantation, a new stent was unpacked and successfully implanted, and the damaged stent was sealed.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the superior vena cava.After lesion preparation, a 12x90/8fr uni plus halo 75cm wallstent endoprosthesis was selected for use.However, prior to implanting, it was found that the stent was fractured.In order to avoid adverse events after implantation, a new stent was unpacked and successfully implanted, and the damaged stent was sealed.There were no patient complications reported and the patient status was stable.It was further reported that the shaft was kinked and not stent damaged as what was previously reported.The kink mark was located in the middle of the shaft.
Additional Manufacturer Narrative
E1- initial reporter address 1: (b)(6).E1- initial reporter phone: (b)(6).(b5) describe event or problem updated.Device evaluated by mfr.: the device was returned for analysis.The device was received with the stent fully deployed from the device.The deployed stent was not returned for analysis.A visual and tactile examination identified no kinks, damage or issues with the delivery system or tip of the device.This concludes the product analysis.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16876538
• Report Number: 2124215-2023-21350
• Device Sequence Number: 7256435
• Product Code: MAF
• UDI-Device Identifier: 08714729203971
• UDI-Public: 08714729203971
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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: 08/31/2024
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0030067742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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: Male
• Patient Weight: 70 KG