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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-NTW
Device Problems Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/19/2024
Event Type  malfunction  
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.H6: device code 2017 - failure to follow steps / instructions.
 
Event Description
It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4+.When inserting the ntw lot; 30724r1044 clip delivery system, insertion was difficult as it not performed co-axially resulting in the hemostasis valve breaking.Air entered the steerable guide catheter requiring aspiration to avoid air entering the patient.A replacement sgc was used to implant ntw lot; 30724r1044 and nt lot: 30609r1039nt successfully, reducing mr to grade 1.There was no 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 the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated and based on the information provided, the reported difficult cds insertion resulting in tearing the silicone valve of the sgc hemostasis valve (device causing damage) appears to be related to user technique of cds insertion.There is no indication of a product 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 Key18895751
MDR Text Key337569331
Report Number2135147-2024-01110
Device Sequence Number1
Product Code NKM
UDI-Device Identifier08717648230974
UDI-Public(01)08717648230974(17)240722(10)30724R1044
Combination Product (y/n)N
Reporter Country CodeSP
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 05/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCDS0702-NTW
Device Lot Number30724R1044
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/19/2024
Initial Date FDA Received03/13/2024
Supplement Dates Manufacturer Received05/02/2024
Supplement Dates FDA Received05/22/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/24/2023
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
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