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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 Activation, Positioning or Separation Problem (2906)
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: 18 years or older.
 
Event or Problem Description
It was reported that stent did not fully expand post deployment.The target lesion was located in the iliac vein.A 14x40/9fr uni plus 75cm wallstent endoprosthesis was advanced for treatment.However, after deployment, the stent head was found not fully opened or the proximal end was still closed.The physician deployed a non-bsc stent to support the original one 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 Key9780153
Report Number2134265-2020-02470
Device Sequence Number2788114
Product Code MAF
UDI-Device Identifier08714729203995
UDI-Public08714729203995
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,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/03/2020
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 Date08/25/2021
Device Model Number26280
Device Catalogue Number26280
Device Lot Number0024326255
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/23/2020
Initial Report FDA Received Date03/03/2020
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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