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

Model Number	26280
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the superior vena cava vein that was completely closed by tumor compression.After pre-dilation, a 24x45/11fr uni plus 75cm wallstent endoprosthesis self expanding stent was selected for use and was pre-deployed in vitro.However, it was noted that the tip of the stent struts were lifted up.The device was replaced with another of the same device and the procedure was completed.No patient complications were reported and patient is stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The device was received with the stent fully mounted on the device.The investigator deployed the stent without experiencing any resistance or issues.No damage or issues were noted with the deployed stent/stent wires.A visual and microscopic examination identified no damage to the stent cups or stent holder that could have contributed to the complaint incident.A visual and tactile examination identified no issues with the delivery system that could potentially have contributed to the complaint incident.No issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the superior vena cava vein that was completely closed by tumor compression.After pre-dilation, a 24x45/11fr uni plus 75cm wallstent endoprosthesis self expanding stent was selected for use and was pre-deployed in vitro.However, it was noted that the tip of the stent struts were lifted up.The device was replaced with another of the same device and the procedure was completed.No patient complications were reported and patient is stable.

• 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: 8861335
• Report Number: 2134265-2019-09217
• Device Sequence Number: 10917028
• Product Code: JCT
• UDI-Device Identifier: 08714729204169
• UDI-Public: 08714729204169
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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: 07/28/2019
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0020943588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 62