LOTUS EDGE VALVE SYSTEM 10394

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 2020-03-31 for LOTUS EDGE VALVE SYSTEM 10394 manufactured by Boston Scientific Corporation.

Event Text Entries

[187262938] It was reported that vessel perforation occurred. Procedure summary: patient anatomy was mildly tortuous. Annulus diameter was 26mm. Access site was right femoral vessel. During the insertion of the 27mm lotus edge valve into a large lotus introducer sheath (lis), high resistance was felt at 6cm to 10cm into the lis. The 27mm lotus edge valve was stuck inside the lis. An attempt to remove the lotus edge valve was not successful. Next an attempt to move the valve forward was done, and an audible pop was heard. The valve moved forward and the resistance suddenly disappeared. Fluoroscopy indicated that the proximal part of the lis moved forward into thoracic aorta with the proximal part of the lotus edge still inside the lis. The lotus edge valve and lis were removed together from the patient. The procedure completed with another large lis and a new 27mm lotus edge valve system. After a non-bsc closure device was used, strong bleeding in the right groin was seen. The perforation was treated with a femoral vessel stent. The patient is doing well.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03078
MDR Report Key9903584
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Device Manufacturer Date2019-10-13
Date Added to Maude2020-03-31
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 IRELAND LIMITED
Manufacturer StreetBALLYBRIT BUSINESS PARK
Manufacturer CityGALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLOTUS EDGE VALVE SYSTEM
Generic NameLOTUS EDGE TM VALVE SYSTEM 27 MM
Product CodeNPT
Date Received2020-03-31
Model Number10394
Catalog Number10394
Lot Number0024588206
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 2020-03-31

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