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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 Codes Defective Device (2588); Migration (4003)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/07/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Age at time of event: above 18 years and older.
 
Event or Problem Description
It was reported that stent migration and stent foreshortening were encountered.The target lesion was located in the stenosed iliac vein.A 14x60/9fr uni plus 75cm wallstent endoprosthesis stent was advanced for treatment.However, after deployment, the stent was found moved and shortened.The physician deployed another of the same device to fix the issue and the procedure was completed.No patient complications were reported and the patient's status was stable.
 
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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 Key9764099
Report Number2134265-2020-02173
Device Sequence Number13579179
Product Code MAF
UDI-Device Identifier08714729204008
UDI-Public08714729204008
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
K152842
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/27/2020
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 Date06/23/2021
Device Model Number26280
Device Catalogue Number26280
Device Lot Number0024000228
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/07/2020
Initial Report FDA Received Date02/27/2020
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 Required Intervention;
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