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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD); MITRAL VALVE REPAIR DEVICES
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ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD); MITRAL VALVE REPAIR DEVICES Back to Search Results
Catalog Number CDS0702-NT
Device Problems Incomplete Coaptation (2507); Device Damaged by Another Device (2915)
Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)
Event Date 02/14/2024
Event Type  Injury  
Event Description
It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.It was noted two mitraclips were previously implanted, but the patient returned to the hospital due to progression of disease.An nt clip (30724r1080) was inserted and deployed on the mitral valve.To further reduce mr, a second xt clip (30612r1031) was inserted.However, during placement of the second clip, it interacted with the first implanted clip.The first implanted clip dislodged and detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda), causing mr to increase.The second clip was repositioned and deployed.Mr worsened to a grade of 4.There was no clinically significant delay in the procedure.
 
Manufacturer Narrative
The clip remains in the 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.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.
 
Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the lot.Additionally, a review of the complaint history identified no similar complaints from the lot.The reported device damaged by another device (dislodged) and slda appear to be related to procedural conditions, and due to the second clip interacting with this first implanted clip, causing slda of this first implanted clip.Mitral valve insufficiency/ regurgitation appears to be related to the slda.Mitral regurgitation is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.Unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.Na.
 
Event Description
It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.It was noted two mitraclips were previously implanted, but the patient returned to the hospital due to progression of disease.An nt clip (30724r1080) was inserted and deployed on the mitral valve.To further reduce mr, a second xt clip (30612r1031) was inserted.However, during placement of the second clip, it interacted with the first implanted clip.The first implanted clip dislodged and detached from the anterior leaflet and remained attached to the posterior leaflet (single leaflet device attachment/slda), causing mr to increase.The second clip was repositioned and deployed.Mr worsened to a grade of 4.There was no clinically significant delay in the procedure.Subsequent to the initially filed report, additional information was received stating to stabilize the slda, an additional clip was attempted but unable to be deployed.
 
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Brand Name
MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
Type of Device
MITRAL VALVE REPAIR DEVICES
Manufacturer (Section D)
ABBOTT MEDICAL
5050 nathan lane n
plymouth MN 55442
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005070406
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key18847958
MDR Text Key337023908
Report Number2135147-2024-01016
Device Sequence Number1
Product Code NKM
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P100009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCDS0702-NT
Device Lot Number30724R1080
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/12/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/25/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CLIP DELIVERY SYSTEM; IMPLANTED MITRACLIP (X2); STEERABLE GUIDE CATHETER
Patient Outcome(s) Required Intervention;
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