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

Model Number	H965403330
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).G4 - premarket / 510(k) #: k152842, k980163, p980033.Device evaluated by mfr: the wallstent endoprosthesis device was returned for analysis.A visual and tactile examination identified an outer sheath kink approximately 745mm proximal from the distal tip, and an inner sheath kink approximately 95mm proximal from the distal tip.The stent was returned sheathed on the device.The stent was deployed with resistance experienced due to the outer sheath kink.The stent was found to be damaged at the same location as the sheath kink when it was mounted on the delivery system.A visual examination identified no damage or issues with the stent cups, stent holder, or tip of the returned device.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2025.It was reported that the stent failed to deploy.The 80% stenosed target lesion was located in a mildly tortuous and severely calcified vein.A 16mm x 90mm x 75cm wallstent endoprosthesis self-expanding stent was selected for use.During attempted deployment, the delivery system would not release the stent.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient condition following the procedure was stable.However, device analysis revealed a damaged stent.

• 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: 23687800
• Report Number: 2124215-2025-84234
• Device Sequence Number: 9438710
• Product Code: MAF
• UDI-Device Identifier: 08714729204053
• UDI-Public: (01)08714729204053(17)250801(10)32134773
• 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
• Report Date (Section B): 12/01/2025

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: 08/01/2025
• Device Model Number: H965403330
• Device Catalogue Number: H965403330
• Device Lot Number: 0032134773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 74 KG