MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT RP ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	26265
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: a visual examination found that the stent of the device had been deployed.It is not known when the stent was deployed.The deployed stent was returned for analysis.No damage or issues were noted with the deployed stent.A visual inspection of the stent impression and stent cups identified no issues.The imprinted stent impression was clear on the stent holder.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified a severe kink to the shaft of the device located approximately 130mm distal of the main t- valve.This type of damage is consistent with excessive force being applied to the device no other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 27-oct-2020.It was reported that stent difficulty advancing was encountered.The target lesion was located in the biliary tract.An 8x80x75/ 6f wallstent rp endoprosthesis was used, but could not be advanced after advancing a part of the stent.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed stent detached/separated.

• Brand Name: WALLSTENT RP ENDOPROSTHESIS
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10829581
• Report Number: 2134265-2020-15683
• Device Sequence Number: 11490287
• Product Code: FGE
• UDI-Device Identifier: 08714729406419
• UDI-Public: 08714729406419
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2020

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: 06/13/2021
• Device Model Number: 26265
• Device Catalogue Number: 26265
• Device Lot Number: 0023952953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 73