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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 Problem Leak/Splash (1354)
Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914)
Event Date 04/22/2020
Event Type  Death  
Manufacturer Narrative
The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information. The additional mitraclip device referenced is filed under a separate medwatch report number.
 
Event Description
This is being filed to report the steerable guide catheter (sgc) leak requiring aspiration and air embolism resulting in death. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4. The first ntr mitraclip was deployed at a2p2 without issue. The second clip delivery system (cds) was advanced, a and m knob were applied to gain height to advance to the mitral valve. Once the cds crossed the valve, the device needed to be rotated in order to be parallel to the first clip when it was noted the clip was stuck on the deployed clip and was pulling on it. The cds was pushed out in an attempt to gain distance from the deployed clip however the clip was stuck and unable to be moved at all. Troubleshooting was performed per the instructions for use (ifu) however the clip would not move. M knob was taken off to release tension in the cds and it appeared the clip changed orientation and was rotating towards the deployed clip. The clip then seemed to jump free from the deployed clip. An attempt was made to invert the clip however was unsuccessful and the clip remained stuck under the posterior mitral leaflet (pml). All m was removed and an attempt was made to invert the clip again however there was a lot of tension on the arm positioner knob and the clip arms would not respond. It was thought the chordae was wrapped around the clip arms or grippers, not allowing it to move. An attempt was made to rotate the arm positioner again and it was noted the clip had detached from the cds as the mandrel had broken. An attempt was made to deploy the clip; the lock line and gripper lines were removed. A snare device was advanced and the clip was able to be brought closer to the valve however became stuck under the anterior mitral leaflet (aml). The clip then became disconnected from the mandrel and the snare device lost the clip. The clip was lodged under the aml and not able to be moved. The cds was removed and a 11fr sheath was inserted into the sgc when it was noted column was lost. Aspiration was performed however the patient's blood pressure dropped and the patient crashed. Chest compressions were started. While doing compressions, the physician was able to insert a second snare device and grab the lodged clip and bring it back to the ivc. Chest compressions were performed for 40 minutes however the patient was never resuscitated and died. Per the physician, the cause of death is unknown however it is possible an air embolism entered the patient when column was lost the second time. 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 Key10021101
MDR Text Key189739817
Report Number2024168-2020-04064
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 06/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2020
Device Model NumberSGC0301
Device Catalogue NumberSGC0301
Device Lot Number91114U358
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2019
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: 05/04/2020 Patient Sequence Number: 1
Treatment
1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM
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