WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM 10371

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 2020-03-20 for WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM 10371 manufactured by Boston Scientific Corporation.

Event Text Entries

[184536260] It was reported that device thrombosis occurred. A left atrial appendage (laa) closure procedure was performed on (b)(6) 2020 and a 30mm watchman laa closure device was successfully implanted. Post procedure, the patient was placed on plavix 75mg daily. During a follow-up tee performed on (b)(6) 2020 at the 45-day check-up, thrombus was noted on the device. A complete seal was noted both during the case and there was no change at follow-up. The patient was started on eliquis with the findings.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03374
MDR Report Key9860824
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-20
Date of Report2020-03-20
Date of Event2020-02-26
Date Mfgr Received2020-02-28
Device Manufacturer Date2019-04-19
Date Added to Maude2020-03-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 LAA CLOSURE DEVICE & DELIVERY SYSTEM
Generic NameSYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
Product CodeNGV
Date Received2020-03-20
Model Number10371
Catalog Number10371
Lot Number0023670355
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. Required No Informationntervention 2020-03-20

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