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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 Migration (4003)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/13/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that stent migration occurred.The target lesion was located in the left common iliac vein.A 20x80/10fr uni plus 75cm wallstent endoprosthesis was deployed to treat the lesion.A non-bsc balloon catheter was advanced for post-dilatation; however, when the balloon was placed inside the stent, the stent moved into the inferior vena cava.A 20x55 wallstent was then used to pin the migrated stent to the vessel wall and the procedure was completed.No patient complications were reported.
 
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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 Key9538750
Report Number2134265-2019-16089
Device Sequence Number11356578
Product Code JCT
UDI-Device Identifier08714729204114
UDI-Public08714729204114
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,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/02/2020
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 Date07/17/2021
Device Model Number26280
Device Catalogue Number26280
Device Lot Number0024127534
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/13/2019
Initial Report FDA Received Date01/02/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
BALLOON CATHETER: BARD ATLAS
Outcome Attributed to Adverse Event Required Intervention;
Patient Age53 YR
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