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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 Failure (3270)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/22/2019
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 the stent failed to fully expand post deployment.The target lesion was located in the vein.A 75cm wallstent uni was selected for use however it was noted that the device was not able to fully expand post deployment.Another wallstent was implanted to treat the under expanded stent and the procedure was completed.There were no patient complications 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 Key8803451
Report Number2134265-2019-08373
Device Sequence Number326858
Product Code MAF
UDI-Device Identifier08714729204053
UDI-Public08714729204053
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
K152842
Number of Events Summarized1
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) 07/18/2019
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 Date10/22/2020
Device Model Number26280
Device Catalogue Number26280
Device Lot Number0022830903
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/26/2019
Initial Report FDA Received Date07/18/2019
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 Required Intervention;
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