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

Model Number	26280
Medical Device Problem Codes	Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that premature deployment occurred.The target lesion was located in a lower extremity vein.A 14x90/9fr wallstent endoprosthesis was advanced; however, during introduction, the stent deployed in advance.The device was removed and the procedure was completed with a different device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: received stent inserted in introducer sheath.The stent delivery system was not returned for analysis.The investigator removed the stent from the introducer sheath.The stent was noted to be damaged on one end.
Event or Problem Description
It was reported that premature deployment occurred.The target lesion was located in a lower extremity vein.A 14x90/9fr wallstent endoprosthesis was advanced; however, during introduction, the stent deployed in advance.The device was removed and the procedure was completed with a different device.There were no patient complications reported and the patient status was stable.

• 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: 15280391
• Report Number: 2124215-2022-29688
• Device Sequence Number: 17906013
• 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): 10/04/2022

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: 03/02/2024
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0028981441
• 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: 08/02/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2022
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 64 KG