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

Model Number	26280
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the stent was returned fully deployed from the delivery system.It is not known when deployment occurred.A visual and microscopic examination identified no issues or damage to the deployed stent.A visual and microscopic 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.A visual and tactile examination found no kinks or damage to the shaft of the returned device.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 11-jan-2021.It was reported that stent deployment failure occurred.A 12mmx90mmx75cm wallstent uni stent was used, however; the device was unable to fully deploy.The device was removed and no patient complications were reported.However, returned device analysis revealed the stent was separated from the deployment system.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11197139
• Report Number: 2134265-2021-00388
• Device Sequence Number: 3756174
• Product Code: MAF
• UDI-Device Identifier: 08714729203971
• UDI-Public: 08714729203971
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2021

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: 10/20/2022
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0026217757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1