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

Model Number	26280
Medical Device Problem Codes	Mechanical Problem (1384); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone number: (b)(6).
Event or Problem Description
It was reported that partial stent deployment and removal difficulties occurred.The patient presented with iliac vein compression.The target lesion was located in the common iliac vein.A 12x90/8fr wallstent endoprosthesis was advanced for treatment.However, when the stent was deployed halfway, it became stuck and could no longer be deployed.Attempts were made to withdraw the device, but stent could not be withdrawn.The stent was removed as a whole and upon inspection outside patient, it was noted that the delivery sheath was kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.
Event or Problem Description
It was reported that partial stent deployment and removal difficulties occurred.The patient presented with iliac vein compression.The target lesion was located in the common iliac vein.A 12x90/8fr wallstent endoprosthesis was advanced for treatment.However, when the stent was deployed halfway, it became stuck and could no longer be deployed.Attempts were made to withdraw the device, but stent could not be withdrawn.The stent was removed as a whole and upon inspection outside patient, it was noted that the delivery sheath was kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.It was further reported that the stent could not be reconstrained and could not be deployed.The device was removed through a 10f unspecified sheath.
Additional Manufacturer Narrative
E1- initial reporter phone number: (b)(6).H6 - device codes: updated from difficult to remove (a150207) to mechanical problem (a05).Device evaluated by mfr.A uni plus device was received for analysis.The device was received with the stent unsheathed.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified an outer sheath kink 85mm proximal from the distal tip.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17187366
• Report Number: 2124215-2023-31782
• Device Sequence Number: 15155785
• 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): 08/03/2023

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: 10/03/2024
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0030271979
• 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: 06/07/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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: 42 YR
• Patient Sex: Male
• Patient Weight: 56 KG