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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR

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ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
Model Number SGC0301
Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Patient Problem Atrial Perforation (2511)
Event Date 11/04/2020
Event Type  Injury  
Manufacturer Narrative
The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The additional mitraclip delivery system referenced is filed under a separate medwatch report number.
 
Event Description
This is filed to report atrial perforation, tissue damage, difficult to remove. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4. The steerable guide catheter (sgc) was advanced to the mitral valve, and the first clip was deployed, reducing mr. Then a second clip delivery system (cds) was advanced to the mitral valve; however, the septum tore causing the sgc to lose height. Then the cds dropped below the valve, and the clip became entangled with the chordae. After maneuvering, the clip became freed, but a chordal rupture occurred. A decision was made to remove the sgc and cds from the patient to abort the procedure. After the cds was removed, it was noted that the actuator mandrel was protruding distally. Additional treatment was not performed. The patient is stable. One clip was implanted, reducing mr to 3. There was no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameMITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of DeviceVALVE REPAIR
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005070406
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key10900244
MDR Text Key218242038
Report Number2024168-2020-09898
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/12/2021
Device Model NumberSGC0301
Device Catalogue NumberSGC0301
Device Lot Number00612U112
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/25/2020 Patient Sequence Number: 1
Treatment
1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM
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