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

Model Number	26280
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.An 18x90/10fr wallstent endoprosthesis was advanced for treatment.However, during deployment, the stent failed to expand.The device was removed and it was thought that the device was unraveled or something was preventing proper deployment.The procedure was completed with another wallstent and no patient complications were reported.The patient had a successful outcome.
Event or Problem Description
It was reported that stent damage occurred.An 18x90/10fr wallstent endoprosthesis was advanced for treatment.However, during deployment, the stent failed to expand.The device was removed and it was thought that the device was unraveled or something was preventing proper deployment.The procedure was completed with another wallstent and no patient complications were reported.The patient had a successful outcome.It was further reported that the 60-70% stenosed, compressed morphological target lesion was located in a non-calcified vein.During advancing, through the great saphenous vein and popliteal artery which had significant fibrotic tissue post thrombotic syndrome, some thrombotic tissues were caught at the distal end of the catheter and draped down.During deployment, the stent would not expand normally.A white-ribbon looking material protruding from the distal tip was noted and no stent deformation.The stent was completely reconstrained.

• 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: 8671243
• Report Number: 2134265-2019-06309
• Device Sequence Number: 291408
• Product Code: JCT
• UDI-Device Identifier: 08714729204084
• UDI-Public: 08714729204084
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 06/24/2019

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: 07/10/2020
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0022362751
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 06/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1