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

Model Number	26280
Medical Device Problem Codes	Nonstandard Device (1420); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the stent profile problem occurred.The stenosed target lesion was located in the superior vena cava.A 75cm wallstent endoprosthesis self-expanding was selected for use.During the procedure, the stent could not be deployed as it was found that the length of the stent may be to the heart.The original stent measured 90 mm but was 150 mm inside the patient.The procedure was complete with another of the same device.There were no further complications noted as a result of this event and the patient status was stable post procedure.
Event or Problem Description
It was reported that the stent profile problem occurred.The stenosed target lesion was located in the superior vena cava.A 75cm wallstent endoprosthesis self-expanding was selected for use.During the procedure, the stent could not be deployed as it was found that the length of the stent may be to the heart.The original stent measured 90 mm but was 150 mm inside the patient.The procedure was complete with another of the same device.There were no further complications noted as a result of this event and the patient status was stable post procedure.It was further reported that the target lesion was 70% stenosed, mildly tortuous, and moderately calcified.The product inner pouch matches the outer carton/shelf carton.The stent was found to be the wrong size to the lesion length while inside the patient's body, with 1/3 of it inside the patient's heart.The stent was fully re-constrained during withdrawal.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: the wallstent uni device was returned for evaluation.The stent was returned partially deployed by 7mm.The stent was deployed without issue, and no issues were noted with the stent.The investigator measured the deployed stent with calibrated ruler, and the measurement of the stent was approximately 90mm.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 and to the shaft.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the stent profile problem occurred.The stenosed target lesion was located in the superior vena cava.A 75cm wallstent endoprosthesis self-expanding was selected for use.During the procedure, the stent could not be deployed as it was found that the length of the stent may be to the heart.The original stent measured 90 mm but was 150 mm inside the patient.The procedure was complete with another of the same device.There were no further complications noted as a result of this event and the patient status was stable post procedure.It was further reported that the target lesion was 70% stenosed, mildly tortuous, and moderately calcified.The product inner pouch matches the outer carton/shelf carton.The stent was found to be the wrong size to the lesion length while inside the patient's body, with 1/3 of it inside the patient's heart.The stent was fully re-constrained during withdrawal.

• 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: 23026551
• Report Number: 2124215-2025-62435
• Device Sequence Number: 9819858
• Product Code: MAF
• UDI-Device Identifier: 08714729204015
• UDI-Public: (01)08714729204015(17)260606(10)34180955
• 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,Followup
• Report Date (Section B): 12/05/2025

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: 06/06/2026
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0034180955
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 09/17/2025; 11/11/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/15/2025; 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 72 KG