FDA.reportPublic FDA data

MAUDE MDR 9883903

MDR report key
9883903
Report number
2024168-2020-02940
Event key
0
Event type
3
Date of event
2020-03-05
Date received
2020-03-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. LINDSEY BELL
Address
26531 YNEZ RD. TEMECULA CA 92591 US
Phone
951-951-9519
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MITRACLIP? SYSTEM CLIP DELIVERY SYSTEMVALVE REPAIRABBOTT VASCULARNKMCDS050290823U177R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2601. R

Event Narratives#

N

Patient 1

THE CLIP REMAINS IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

D

Patient 1

THIS IS BEING FILED TO REPORT THE LEAFLET DAMAGE. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. THE CLIP DELIVERY SYSTEM (CDS) WAS ADVANCED AND PLACED ON THE MITRAL VALVE. WHEN THE CLIP WAS FULLY CLOSED ON THE LEAFLETS, IT WAS NOTED THE ANTERIOR LEAFLET WAS TORN. THE CLIP WAS REOPENED AND REPOSITIONED, THEN DEPLOYED, REDUCING MR TO 3. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.