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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
Catalog Number SGC0302
Device Problems Difficult or Delayed Positioning (1157); Improper or Incorrect Procedure or Method (2017)
Patient Problems Death (1802); Hemorrhage/Bleeding (1888)
Event Date 06/15/2020
Event Type  Death  
Manufacturer Narrative
The device location was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
This is filed to report the patient died after the mitraclip procedure. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 2-3. One clip was implanted, reducing mr to <1 with gradient of 3 mmhg. The clip was attached to both leaflets. There was no tissue damage noted. The patient was stable. Immediately after closing the groin ("figure eight stitch") the patient cardiac output dropped suddenly and went into a reanimation setting. The poor left and right ventricle stopped working and after noradrenaline and defibrillation the patient died. Additional information reported that post mortem examination confirmed that because a short stiff wire (180 cm) was used instead of the regular guide wire (260 cm) there was not enough support for the steerable guide catheter (sgc) causing massive bleeding in the body. Additionally, since the procedure had been delay due to covid-19, the patient¿s left ventricle function was much worse than what was initially viewed in the echocardiogram. 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 Key10245026
MDR Text Key197944826
Report Number2024168-2020-05545
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/20/2020
Device Catalogue NumberSGC0302
Device Lot Number91120U308
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 Received08/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2019
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: 07/08/2020 Patient Sequence Number: 1
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