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-NTR manufactured by Abbott Vascular.

Event Text Entries

[187720469] The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event. The reported patient effect of mitral valve injury (tissue damage), as listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures. Based on the information reviewed, the tissue damage was reported to be due to the fragile leaflets and therefore related to patient morphology/pathology. There is no indication of a product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10

[187720470] This is filed to report tissue damage. It was reported that this was a mitraclip procedure performed to treat functional mitral regurgitation (mr), with an mr grade of 4. Echo imaging was challenging. Two clips were implanted reducing mr to 2. To further reduce mr, a third clip (9113u259) was advanced to the mitral valve and the leaflets were grasped. When preparing to remove the lock line, it was noticed that mr increased to 2-3. The lock lever cap was placed back on, securing the lock line in place, unlocking, and removing the clip. A leaflet tear was suspected, due to the fragile leaflets. Another clip, was advanced, but leaflet capture was not successful due to short posterior leaflet and deteriorating echo image. The clip was not implanted and was removed. A total of two clips were implanted, reducing mr to 3. The patient was converted to open heart surgery for mitral replacement. The patient remained stable. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number2024168-2020-03166
MDR Report Key9908012
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-11-14
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

Product CodeNKM
Date Received2020-03-31
Catalog NumberCDS0602-NTR
Lot Number91113U259
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer Address26531 YNEZ RD. TEMECULA CA 925914628 US 925914628


Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit 2020-03-31

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