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

Model Number	26280
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was difficult to remove.The target lesion was located in the iliac vein.A 12x90/8fr wallstent endoprosthesis self-expanding stent was selected for treatment.During the procedure, it was noted that the stent could not be deployed, and it was difficult to withdraw.The procedure was not completed.No complications were reported, and the patient was stable post procedure.
Event or Problem Description
It was reported that the device was difficult to remove.The target lesion was located in the iliac vein.A 12x90/8fr wallstent endoprosthesis self expanding stent was selected for treatment.During the procedure, it was noted that the stent could not be deployed, and it was difficult to withdraw.The procedure was not completed.No complications were reported, and the patient was stable post procedure.It was further reported that the patient was under local anesthesia.The target lesion was located 70% stenosed, moderately tortuous and moderately calcified.The stent was normally recaptured into the catheter.
Additional Manufacturer Narrative
The device was returned for evaluation.The device was received with the stent fully constrained in the correct position on the device.The investigator successfully deployed the stent with no resistance experienced.A visual examination identified no issues or damage to the deployed stent.A visual and tactile examination identified no damage or issues with the tip or delivery system.No other issues were identified during 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21277039
• Report Number: 2124215-2025-02341
• Device Sequence Number: 18275978
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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: 10/25/2025
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0032722174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 61 KG