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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 UNK SGC03
Device Problems Difficult or Delayed Positioning (1157); Unintended Movement (3026)
Patient Problems Air Embolism (1697); Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Perforation (2001); Heart Failure/Congestive Heart Failure (4446)
Event Date 01/01/2022
Event Type  Injury  
Manufacturer Narrative
The device is not returning for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. Date of event is estimated. The udi number is not known as the part and lot number were not provided. Literature attachment: article title: "acute right ventricular failure and right-to-left shunt due to massive coronary air embolism following mitraclip.
 
Event Description
This is filed to report leak, atrial perforation, medical intervention, air embolism, and prolonged hospitalization. It was reported in a literature review that this was mitraclip procedure to treat mitral regurgitation. A steerable guide catheter (sgc) was advanced to the mitral valve, and the clip was successfully deployed. However, after the clip delivery system was removed, the patient developed hypotension, complete atrioventricular block [arrhythmia], and oxygen saturation decreased from 96% to 48%. The patient's hemodynamic were stabilized by oxygen and medication. Imaging showed a left to right shunt. The physician stated that the cause of the shunt was possibly due to the sgc insertion was complicated by severe tricuspid regurgitation and an enlarged right atrium/ventricle. Coronary angiography was performed from the left femoral access due to an inferior st-elevation and showed a coronary flow at the mid right coronary artery that indicated a possible air embolism and heart failure. Several aspirations attempts were made to remove the air. The coronary flow was restored, and the patient was stable. However, post-procedural computed tomography revealed a small amount of air in the right atrium without any signs of systemic embolism. The physician stated the cause of air was possibly due to position of the distal end of the sgc against the left atrial wall when the clip delivery system was removed may have resulted in suction of air in the left atrium indication the sgc may moved in an intended direction. The patient was discharged at 36 days indicating prolonged hospitalization. It is unknown at this time if the left to right shunt was treated. One clip was implanted, reducing, mr. There was no reported 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 Key13834326
MDR Text Key287802965
Report Number2024168-2022-02920
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK SGC03
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/20/2022 Patient Sequence Number: 1
Treatment
1 IMPLANTED MITRACLIP
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