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

Model Number	26280
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was aborted.The patient presented for venous stent implantation.The target lesion was located in the severely stenosed and occluded right iliac vein.After crossing the guidewire into the lesion, pre-dilatation was performed.A 16x40/9fr uni plus 75cm wallstent endoprosthesis stent was advanced for treatment.However, during deployment, the delivery shaft was kinked and the stent could not be implanted.The device was withdrawn and the procedure was not completed due to an unspecified reason.
Event or Problem Description
It was reported that the procedure was aborted.The patient presented for venous stent implantation.The target lesion was located in the severely stenosed and occluded right iliac vein.After crossing the guidewire into the lesion, pre-dilatation was performed.A 16x40/9fr uni plus 75cm wallstent endoprosthesis stent was advanced for treatment.However, during deployment, the delivery shaft was kinked and the stent could not be implanted.The device was withdrawn and the procedure was not completed due to an unspecified reason.It was further reported that target lesion was 95% stenosed, severely tortuous, and severely calcified.There was a large resistance met during delivery of the device.The procedure was cancelled since the lesion did not open.
Additional Manufacturer Narrative
Device evaluated by mfr.: 16x40/9fr uni plus 75cm 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 identified a kink on the shaft of the device located approximately 250mm distal of the main t-valve.This type of damage is consistent with excessive force being applied excessive force to the delivery system.This concludes the product analysis.
Event or Problem Description
It was reported that the procedure was aborted.The patient presented for venous stent implantation.The target lesion was located in the severely stenosed and occluded right iliac vein.After crossing the guidewire into the lesion, pre-dilatation was performed.A 16x40/9fr uni plus 75cm wallstent endoprosthesis stent was advanced for treatment.However, during deployment, the delivery shaft was kinked and the stent could not be implanted.The device was withdrawn and the procedure was not completed due to an unspecified reason.It was further reported that target lesion was 95% stenosed, severely tortuous, and severely calcified.There was a large resistance met during delivery of the device.The procedure was cancelled since the lesion did not open.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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: 15991290
• Report Number: 2124215-2022-50157
• Device Sequence Number: 17570346
• Product Code: MAF
• UDI-Device Identifier: 08714729204039
• UDI-Public: 08714729204039
• 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,Followup
• Report Date (Section B): 01/25/2023

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: 12/09/2022
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0026489797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/24/2022
• Supplement Date Received by Manufacturer: 12/12/2022; 01/04/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/03/2023; 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2020
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 60 KG