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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number 26280
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/11/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that stent damage occurred.A 18x90mm wallstent endoprosthesis was selected for use for a stenting procedure in the left iliac vein.While the physician was attempting to deploy the stent, the stent collapsed on itself.The physician then had to use a 16x90mm wallstent endoprosthesis, however, the same issue began to occur when the physician attempted deployment.The stent was retracted and removed.Another 16x90mm wallstent endoprosthesis was then used to complete the procedure with no issues.There were no patient complications and the patient was fine post procedure.
 
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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 Key8379197
Report Number2134265-2019-01867
Device Sequence Number14206837
Product Code JCT
UDI-Device Identifier08714729204084
UDI-Public08714729204084
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K152842
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/28/2019
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 Date12/16/2020
Device Model Number26280
Device Catalogue Number26280
Device Lot Number23096677
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/11/2019
Initial Report FDA Received Date02/28/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age26 YR
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