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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 Code Available (3191)
Date of Event 07/10/2020
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 damage occurred.The 92% stenosed target lesion was located in the moderately tortuous and non-calcified subclavian vein.A 16x40/9fr uni plus 75cm wallstent endoprosthesis was advanced for treatment.However, the device was stuck with the catheter.The physician deployed the device but the stent was found slightly tortuous.Another wallstent was deployed to cover the lesion.The procedure was completed with no patient complications 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 Key10363221
Report Number2134265-2020-10430
Device Sequence Number19487294
Product Code MAF
UDI-Device Identifier08714729204039
UDI-Public08714729204039
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) 08/04/2020
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 Date09/30/2021
Device Model Number26280
Device Catalogue Number26280
Device Lot Number0024522340
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/28/2020
Initial Report FDA Received Date08/04/2020
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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