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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Respiratory Distress (2045); Heart Failure (2206); Atrial Perforation (2511)
Event Date 06/06/2020
Event Type  Death  
Manufacturer Narrative
Date of event/death - estimated. The unique device identifier (udi) is unknown because the part and lot numbers were not provided. The device was not returned for analysis. The lot history record (lhr) review was not performed because no device/lot information was provided. The reported patient effects of death, atrial perforation, heart failure and respiratory distress as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures. Based on the available information, a definitive cause for the reported death appears to be procedure related. Furthermore, a definitive cause for the reported patient effects of atrial perforation, heart failure and respiratory distress could not be determined. Although, a conclusive cause for the reported patient effects, and the relationship to the device, if any, cannot be determined. There is no indication of a product issue with respect to manufacture, design, or labeling.
 
Event Description
This is filed to report the patient death. It was reported that a mitraclip procedure was performed to treat mitral regurgitation. The procedure was successful, one clip was implanted successfully. The case went very well. However, after the procedure as the patient recovered from anesthesia, right heart pressures increased resulting in a right to left shunt. Sometime over the weekend, the patient desaturated and died. There was no abnormal tearing of the septum besides the inherent septal access with steerable guide catheter. Per the physician the patient death is procedure related, due to the septal access, but it is unknown if the patient would have decompensated without the septal hole. 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 Key10176883
MDR Text Key195881173
Report Number2024168-2020-05198
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
Report Date 06/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK SGC03
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 Received06/08/2020
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: 06/19/2020 Patient Sequence Number: 1
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