MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM CDS0602-XTR

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 MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM CDS0602-XTR manufactured by Abbott Vascular.

Event Text Entries

[186376878] Date of event - estimated, implant date - estimated, explant date - estimated. The device was discarded. Investigation is not yet complete. A follow-up will be submitted with all relevant information. Attached article,:? Transcatheter edge-to-edge tricuspid repair for recurrence of valvular regurgitation after left ventricular assist device and tricuspid ring implantation.?
Patient Sequence No: 1, Text Type: N, H10


[186376879] This is filed to report the single leaflet device attachment/slda. It was reported through a research article; the mitraclip procedure was performed in a patient with a left ventricular assist device, and a previous rigid ring in the tricuspid valve as adjunctive bridge to heart transplantation. Two clips were implanted in the tricuspid valve, reducing tr. Approximately one month post clip implantation, the patient went in for a heart transplant and it was noted that one clip detached from the septal leaflet, and remained attached to the anterior leaflet (slda). Details are listed in the attached article, titled? Transcatheter edge-to-edge tricuspid repair for recurrence of valvular regurgitation after left ventricular assist device and tricuspid ring implantation.? Please see article for additional information.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-03188
MDR Report Key9908721
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2019-06-01
Date Mfgr Received2020-03-10
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 ContactMS. LINDSEY BELL
Manufacturer Street26531 YNEZ RD.
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal925914628
Manufacturer Phone9519143996
Manufacturer G1ABBOTT VASCULAR, REG # 3005070406
Manufacturer Street3885 BOHANNON DRIVE
Manufacturer CityMENLO PARK CA 94025
Manufacturer CountryUS
Manufacturer Postal Code94025
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMITRACLIP? SYSTEM CLIP DELIVERY SYSTEM
Generic NameVALVE REPAIR
Product CodeNKM
Date Received2020-03-31
Catalog NumberCDS0602-XTR
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT VASCULAR
Manufacturer Address26531 YNEZ RD. TEMECULA CA 925914628 US 925914628


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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