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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT RP ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE
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BOSTON SCIENTIFIC CORPORATION WALLSTENT RP ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE Back to Search Results
Model Number 26265
Medical Device Problem Codes Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 03/20/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a stent migration occurred.The stenosed target lesion was located in an unknown artery.A 10x42x75 unistep plus stent self expanding was advanced for treatment however it foreshortened post deployment.Another 10x68x75 unistep plus stent self expanding was deployed.However, after checking the fluoroscopy, the stent migrated to the heart.The procedure was ended and the patient was transferred to another hospital for open heart surgery.The devices were removed by a cardiovascular surgeon.The patient status was stable post surgical explant.
 
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Brand Name
WALLSTENT RP ENDOPROSTHESIS
Common Device Name
PROSTHESIS, TRACHEAL, EXPANDABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8492572
Report Number2134265-2019-03604
Device Sequence Number11144155
Product Code MIR
UDI-Device Identifier08714729406471
UDI-Public08714729406471
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K992510
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/08/2019
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 Date02/14/2021
Device Model Number26265
Device Catalogue Number26265
Device Lot Number0023353621
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/20/2019
Initial Report FDA Received Date04/08/2019
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 Hospitalization; Other; Required Intervention;
Patient Age48 YR
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