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

Model Number	26280
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2018.It was reported that crossing difficulties were encountered.The target lesion was a deep vein thrombosis located in the lower extremity.A 12x90/8fr 75cm wallstent endoprosthesis stent was advanced but failed to cross the superficial femoral vein despite several attempts.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed stent damage.The device was returned for analysis.The stent was returned partially deployed on the delivery system.It is not known when deployment occurred.The investigator successfully deployed the stent without resistance or any issues being experienced.A visual and microscopic examination identified damage to the distal wires of the deployed stent.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified no issues with the shaft of the device.No other issues were identified during analysis.

• 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: 7960228
• Report Number: 2134265-2018-61875
• Device Sequence Number: 16537171
• Product Code: MAF
• UDI-Device Identifier: 08714729203971
• UDI-Public: 08714729203971
• 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
• Report Date (Section B): 10/12/2018

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: 04/08/2020
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0021967305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR