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

Model Number	26280
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent prematurely deployed.The target lesion was located in the stenosed precava.A 24x70/11fr uni plus 75cm wallstent endoprosthesis was advanced for treatment.However, during the procedure, the stent deployed in the postcava.The physician tried to snare the stent but failed.The stent was left in the postcava and the physician planned to re-attempt snaring the device out in a couple days.The procedure was completed with another of the same device.No further patient complications nor injuries were reported and the patient 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: 9140978
• Report Number: 2134265-2019-11810
• Device Sequence Number: 1824730
• Product Code: JCT
• UDI-Device Identifier: 08714729204176
• UDI-Public: 08714729204176
• 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): 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2021
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0023308450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR