WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for WATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM manufactured by Boston Scientific Corporation.

Event Text Entries

[187708318] Date of event is approximated since unknown.
Patient Sequence No: 1, Text Type: N, H10


[187708319] It was reported that thrombus on the device occurred. A left atrial appendage (laa) closure procedure was performed. A watchman flx laa closure device was implanted in the laa of the patient. The patient was put on clopidogrel and aspirin for a year since the patient has a stent. During a follow up transesophageal echocardiogram (tee), a non-mobile thrombus was noted on the closure device. It was suspected the closure device moved a little proximal, but it was not confirmed. There was no leak noted with the closure device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03911
MDR Report Key9884002
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-03-01
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-26
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 ContactJAY JOHNSON
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634942574
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer StreetBALLYBRIT BUSINESS PARK
Manufacturer CityGALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWATCHMAN FLX LAA CLOSURE DEVICE & DELIVERY SYSTEM
Generic NameSYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
Product CodeNGV
Date Received2020-03-26
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. Other 2020-03-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.