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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); Difficult to Insert (1316); Deformation Due to Compressive Stress (2889)
Patient Problems Anemia (1706); Cardiac Arrest (1762); Death (1802); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Tissue Damage (2104)
Event Date 08/26/2020
Event Type  Death  
Manufacturer Narrative
The customer reported the device is returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The clip delivery system (cds) is filed under a separate medwatch report number.
 
Event Description
This is filed to report possible vein injury and death. It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 3. The steerable guide catheter (sgc) was advanced. It was noted that there was resistance during insertion into the groin due to vessel tortuosity. The sgc was able to be advanced with resistance. It was observed under fluoroscopy that the sgc tip was bent down; therefore, the sgc was removed. The groin and abdomen were checked under echocardiogram and it was confirmed that there were no injuries. A new transseptal puncture was performed and the second sgc was advanced without issue. The clip delivery system (cds) was advanced, but was difficult to control and position due to the position of the sgc in a muscular portion of the valve; therefore, a second puncture was considered. The cds and sgc were retracted to the right atrium; however, the patient experienced tachycardia and hypotension, and the pacer was started repeatedly. The groin and pericardium were checked and no bleeding was visible. The patient was reanimated, but died. In the physicians opinion, the death was due to poor cardiac performance, repeated use of the pacer. Additionally, the physician suspected that there was a small hemorrhage in the groin due to the sgc bend, which the patient was not able to compensate for and it was noted that the patient was experiencing anemia. 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 Key10547248
MDR Text Key207341714
Report Number2024168-2020-07783
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
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 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/07/2021
Device Catalogue NumberSGC0302
Device Lot Number00406U346
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2020
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: 09/17/2020 Patient Sequence Number: 1
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