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

Model Number	26280
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred and the procedure was cancelled.The 100% stenosed target lesion was located in the non-tortuous and non-calcified right common iliac vein.A 18x60/10fr uni plus 75cm was advanced through a 13fr non-bsc sheath to treat the lesion.However, during deployment, the distal end of the stent would not open on multiple attempts.The device was recaptured and was completely removed outside the patient's body.The physician attempted to deploy on the table but the stent would still not open and it was noticed that the edges were mangled.No replacement stents were available so the procedure was cancelled.No patient complications were reported and the patient status was 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: 10482382
• Report Number: 2134265-2020-12167
• Device Sequence Number: 3394963
• Product Code: JCT
• UDI-Device Identifier: 08714729204077
• UDI-Public: 08714729204077
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/02/2020

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: 05/06/2021
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0023753482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 13FR INARI
• Patient Age: 69 YR