WALLSTENT RP ENDOPROSTHESIS 26265

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-08 for WALLSTENT RP ENDOPROSTHESIS 26265 manufactured by Boston Scientific Corporation.

Event Text Entries

[141234011] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2019-03603
MDR Report Key8492567
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-04-08
Date of Report2019-04-08
Date of Event2019-03-20
Date Mfgr Received2019-03-20
Device Manufacturer Date2019-02-15
Date Added to Maude2019-04-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSONALI ARANGIL
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone6515827403
Manufacturer G1BOSTON SCIENTIFIC IRELAND LIMITED
Manufacturer StreetBALLYBRIT BUSINESS PARK
Manufacturer CityGALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWALLSTENT RP ENDOPROSTHESIS
Generic NamePROSTHESIS, TRACHEAL, EXPANDABLE
Product CodeMIR
Date Received2019-04-08
Model Number26265
Catalog Number26265
Lot Number0023353620
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention 2019-04-08

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