MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM CDS0601-XTR

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 2020-03-31 for MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM CDS0601-XTR manufactured by Abbott Vascular.

Event Text Entries

[189057015] The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10


[189057016] This is filed for clip caught in the chordae, requiring surgical intervention. 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 prepared for use and no issues were noted. The cds was advanced into the patient anatomy. The clip arms were opened to position over the valve. The clip arms were then closed and the cds was advanced below the valve. An attempt was made to open the clip arms, but the clip would not open. Standard troubleshooting was performed and the clip opened. The clip was able to grasp the leaflets; however, the decision was made to re-grasp at another leaflet location. The clip would not open and standard troubleshooting was performed. The clip opened, but became caught in the chordae. It was noted that the lock line was disconnected inside the clip delivery system handle. Troubleshooting was performed; however, the clip could not be removed from the chordae and the decision was made to deploy the clip where it was caught. The clip was deployed on the chordae only. The patient was then sent to surgery for a mitral valve replacement procedure. Post surgical procedure, the patient was in stable condition. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-03182
MDR Report Key9908568
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-09-25
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
Model NumberCDS0601-XTR
Catalog NumberCDS0601-XTR
Lot Number90920U190
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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
101. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit 2020-03-31

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