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

Model Number 26280

Device Problems Material Deformation (2976); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2019

Event Type  malfunction  

Event 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 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
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8671243
• MDR Text Key: 147082565
• Report Number: 2134265-2019-06309
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 08714729204084
• UDI-Public: 08714729204084
• Combination Product (y/n): N
• PMA/PMN Number: K152842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 05/31/2019
• Supplement Dates FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1