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

Model Number	26280
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent was deployed in an unintended place.The target lesion was located in the left iliac vein.A 75 cm wallstent endoprosthesis stent was advanced for treatment.However, there was difficulty deploying the stent.When the physician deployed the stent, the stent was deployed in unintended location.A second stent was then deployed to treat the intended lesion.No patient complications were reported and the patient was stable post procedure.

• 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: 9369143
• Report Number: 2134265-2019-14385
• Device Sequence Number: 11479813
• Product Code: MAF
• UDI-Device Identifier: 08714729203964
• UDI-Public: 08714729203964
• 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): 11/25/2019

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: 06/25/2020
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0022301762
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 11/25/2019
• 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: 48 YR
• Patient Weight: 55