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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 CDS0705-NTW
Device Problem Unstable (1667)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2023
Event Type  Injury  
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.
 
Event Description
It was reported that a patient presented with grade 4 degenerative mitral regurgitation (mr) and a prolapsed posterior leaflet for a mitraclip procedure.The physician believes the screws on the delivery catheter (dc) fasteners are not tight enough.The procedure was completed without any problems using the original fastener.Comparing the shape of the tip with the long fastener for the stabilizer, the fastener on the dc handle is rounder.The dc handle did not have the same amount of resistance as normal and rotation felt looser.The dc handle was operated carefully and held to prevent rotation during the procedure in a preventive and safe manner.There was no malfunction or unintended movement.The physician pointed out that he was able to move more easily than normal in the rotational direction.He suggested that the shape of the screw tip (e.G., square or round) can affect mobility.The mr was reduced to grade 1.There were no adverse patient effects or clinically significant delay.
 
Manufacturer Narrative
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 this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the cause of the reported unstable dc fastener was unable to be determined.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
 
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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 Key18409640
MDR Text Key331502202
Report Number2135147-2023-05742
Device Sequence Number1
Product Code NKM
Combination Product (y/n)N
Reporter Country CodeJA
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 01/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/15/2024
Device Catalogue NumberCDS0705-NTW
Device Lot Number30215R1048
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/04/2023
Initial Date FDA Received12/28/2023
Supplement Dates Manufacturer Received01/10/2024
Supplement Dates FDA Received01/18/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2023
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
STEERABLE GUIDE CATHETER
Patient Outcome(s) Required Intervention;
Patient Age82 YR
Patient SexFemale
Patient Weight47 KG
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