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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 Respiratory Distress (2045); Atrial Perforation (2511)
Event Date 11/01/2020
Event Type  Injury  
Manufacturer Narrative
The customer reported the device is not returning. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. Literature article title ¿iatrogenic atrial septal defect after percutaneous mitral valve repair with mitraclip:should we consider closing them routinely¿.
 
Event Description
This is filed to report respiratory distress and atrial perforation. It was reported through a research article that a patient underwent a mitraclip procedure to treat functional mitral regurgitation (mr) with an unknown grade. One clip was successfully implanted, successfully reducing mr. However, after the clip was implanted, echocardiography showed an abrupt oxygen desaturation. A right to left shunt was then observed. To treat the shunt, an 12mm closure device was implanted. After the closure device was implanted, the patient showed immediate hemodynamic improved. Details are listed in the article, titled ¿iatrogenic atrial septal defect after percutaneous mitral valve repair with mitraclip: should we consider closing them routinely?" 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 Key10928740
MDR Text Key218988997
Report Number2024168-2020-10038
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeSP
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 12/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2020
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 Received12/01/2020
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: 12/01/2020 Patient Sequence Number: 1
Treatment
IMPLANTED MITRACLIP
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