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 2020-03-30 for MITRACLIP? SYSTEM CLIP DELIVERY SYSTEM CDS0602-XTR manufactured by Abbott Vascular.

Event Text Entries

[186797176] The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported issue. Based on the information reviewed, the reported patient effect was determined to be a combination of patient anatomy and procedural circumstances. The reported patient effect of tissue damage as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures. There is no indication of a product issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10


[186797177] This is being filed to report tissue damage. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4. It was noted long and thin posterior mitral leaflet (pml). A clip delivery system (cds) was advanced to the mitral valve; however, during closing of the clip, the posterior mitral leaflet became perforated. The cds was removed with the clip attached and the procedure was aborted. The tissue damage was not treated. No clips were implanted, and mr is 3-4. There was no reported clinically significant delay in the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-03064
MDR Report Key9897152
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-12-26
Date Added to Maude2020-03-30
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 Received2020-03-30
Catalog NumberCDS0602-XTR
Lot Number91221U105
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
101. Other 2020-03-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.