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

Model Number	26280
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: a visual examination of the returned device found that the stent had been fully deployed from the device.The delivery system was not returned for analysis.A visual examination found the distal wires of the deployed stent to be damaged.No other issues were identified with the device during analysis.
Event or Problem Description
Reportable based on device analysis completed on 17jan2022.It was reported that stent deployment failure occurred.The patient had thrombosis on both lower limbs and needed 5 wallstent stents to be implanted.A 75cm wallstent endoprosthesis self-expanding stent was advanced for treatment as a second stent; however, it could not be deployed.The device was removed and the procedure was completed with another of the same device.There were no complications nor injuries reported and the patient status was stable.However, returned device analysis revealed that the stent was detached and the stent wires were damaged.
Event or Problem Description
Reportable based on device analysis completed on 17jan2022.It was reported that stent deployment failure occurred.The patient had thrombosis on both lower limbs and needed 5 wallstent stents to be implanted.A 75cm wallstent endoprosthesis self-expanding stent was advanced for treatment as a second stent; however, it could not be deployed.The device was removed and the procedure was completed with another of the same device.There were no complications nor injuries reported and the patient status was stable.However, returned device analysis revealed that the stent was detached and the stent wires were damaged.It was further reported that the stent was intentionally deployed by the physician, after it was withdrawn from the patient, to see if the stent could be deployed outside the patient.
Additional Manufacturer Narrative
Device evaluated by mfr.: a visual examination of the returned device found that the stent had been fully deployed from the device.The delivery system was not returned for analysis.A visual examination found the distal wires of the deployed stent to be damaged.No other issues were identified with the device during analysis.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13485429
• Report Number: 2134265-2022-01089
• Device Sequence Number: 5462003
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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: 10/23/2022
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0026237584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2020
• 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: 70 KG