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

Model Number	26280
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a vein.A 14x90/9fr uni plus 75cm wallstent endoprosthesis was advanced for treatment.However, the stent strut was kinked and could not be deployed.The procedure was completed with another of the same device.There were no patient complications reported.The patient was stable after the procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The stent was returned unsheathed on the delivery system.The stent was deployed without issue and no issues were noted with the stent.A visual examination identified no damage or issues with the stent cups or stent holder of the returned device.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified no issues.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a vein.A 14x90/9fr uni plus 75cm wallstent endoprosthesis was advanced for treatment.However, the stent strut was kinked and could not be deployed.The procedure was completed with another of the same device.There were no patient complications reported.The patient was stable after the procedure.

• 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: 15214348
• Report Number: 2124215-2022-28723
• Device Sequence Number: 17358146
• Product Code: MAF
• UDI-Device Identifier: 08714729204015
• UDI-Public: 08714729204015
• 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): 09/19/2022

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: 09/16/2023
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0028033572
• 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: 07/25/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• 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: 77 YR
• Patient Sex: Male