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

Model Number	26280
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.:the device was returned for analysis.The stent was returned fully mounted in the correct location on the delivery system.The investigator successfully deployed the stent with no resistance or issues experienced.A visual and microscopic examination identified damage to the distal stent wires of the deployed stent.This type of damage is consistent with the stent encountering resistance during deployment.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 damage or issues with 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 06jan2020.It was reported that stent deployment failure occurred.The target lesion was located in the inferior vena cava vein.A 24x45/11fr uni plus 75cm wallstent endoprosthesis was advanced for treatment.However, the distal end of the stent would not open up when tried to deploy.Subsequently, the physician reconstrained the stent and tried to deploy it again but was unsuccessful.The device was then removed in a fully reconstrained state and another 22x45 wallstent was used to complete the procedure.No patient complications were reported.However, returned device analysis revealed stent damage.

• 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: 9612216
• Report Number: 2134265-2020-00282
• Device Sequence Number: 11447729
• Product Code: JCT
• UDI-Device Identifier: 08714729204169
• UDI-Public: 08714729204169
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2020

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 Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0023723572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR