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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR); MITRAL VALVE REPAIR DEVICES

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ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR); MITRAL VALVE REPAIR DEVICES Back to Search Results
Catalog Number CDS0706-NT
Device Problem Positioning Failure (1158)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 03/05/2024
Event Type  Injury  
Manufacturer Narrative
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 functional mitral regurgitation (mr), calcium on the posterior annulus, and normal leaflets for a mitraclip procedure.It was noted that imaging was challenging, due to shadowing from the devices in use.One ntw clip was implanted.A second ntw (30607a1082) was perpendicular to the line of coaptation and of leaflet insertion assessment (lia) was satisfactory in all views.After deployment there was a single leaflet device attachment (slda) of the 2nd ntw clip.Detachment from the posterior leaflet was noted.There was no tissue damage noted after the slda.Per the physician, the challenging imaging contributed to the slda.A third clip, an nt (30322r1071), was to be placed lateral to the slda clip for stabilization.Both leaflets were grasped at first, but then a loss of leaflet capture with the posterior leaflet occurred.The nt was unable and noted to be difficult to grasp both leaflets simultaneously and independently.The nt clip damaged the posterior leaflet (appeared tattered).An xt was used as a replacement, but both leaflets were unable to be grasped independently or simultaneously.The clip was removed and the procedure was discontinued.The patient was stable throughout and at the end, despite a prolonged procedure.There were no additional treatments for the leaflet injury or slda.
 
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.The investigation was unable to determine a cause for the reported inability to grasp and inability to capture the leaflets.The reported poor image resolution was due to shadowing from the devices in use.The reported tissue injury (damaged posterior leaflet) appears to be related to multiple grasping and capturing attempts.Tissue injury is listed in the instructions for use as a known possible complication associated with mitraclip procedures.The reported serious injury/illness/impairment was a result of case specific circumstance as no treatment was provided for the tissue injury.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 (MDR)
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 Key18987238
MDR Text Key338719650
Report Number2135147-2024-01363
Device Sequence Number1
Product Code NKM
UDI-Device Identifier05415067037367
UDI-Public(01)05415067037367(17)240320(10)30322R1071
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/19/2024
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? No
Device Operator Health Professional
Device Expiration Date03/20/2024
Device Catalogue NumberCDS0706-NT
Device Lot Number30322R1071
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/05/2024
Initial Date FDA Received03/27/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/19/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/22/2023
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
MITRACLIP; STEERABLE GUIDE CATHETER
Patient Outcome(s) Other;
Patient Age82 YR
Patient SexFemale
Patient Weight48 KG
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