CDS07 CDS0701-XTW

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 2020-03-30 for CDS07 CDS0701-XTW manufactured by Abbott Vascular.

Event Text Entries

[187713893] The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. Additionally, a review of the complaint did not indicate a lot-specific product issue. All information was investigated and a cause for the reported slda in this complaint could not be determined. The reported patient effect of persistent or residual mitral regurgitation as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures. The reported mr was likely due to the slda. There is no indication of a product issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10


[187713894] This is being filed to report that the clip detached from one leaflet and the mr increased. It was reported that the initial mitraclip procedure was performed on (b)(6) 2020, to treat mixed mitral regurgitation (mr) with a grade of 4. One clip was implanted, reducing mr to 1-2. On (b)(6) 2020, the patient returned for a follow up where it was noted the clip had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment (slda)). The mr increased to 4. No treatment is planned at this time and the patient will be medically managed. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-03116
MDR Report Key9901309
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-11
Date Mfgr Received2020-03-12
Device Manufacturer Date2019-10-23
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 NameCDS07
Generic NameVALVE REPAIR
Product CodeNKM
Date Received2020-03-30
Model NumberCDS0701-XTW
Catalog NumberCDS0701-XTW
Lot Number91019U192
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

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