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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 SGC01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation (2001); Cardiogenic Shock (2262); Heart Failure/Congestive Heart Failure (4446)
Event Date 11/27/2016
Event Type  Injury  
Manufacturer Narrative
Date of event: estimated date. The udi number is not known as the part and lot number were not provided. The device will not be returned for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. Literature article title: haemodynamic and functional consequences of the iatrogenic atrial septal defect following mitraclip therapy.
 
Event Description
This is being filed to report the atrial septal defect (asd), heart failure, cardiogenic shock, and treatment. It was reported via literature that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+. The mitraclip was successfully implanted. The patient rapidly deteriorated following the clip placement. Echocardiographic imaging revealed a bidirectional shunt, predominantly left-to-right. Acute right heart failure and cardiogenic shock prompted iatrogenic atrial septal defect (iasd) closure with an amplatzer device, after which the patient showed immediate haemodynamic improvement. No additional information was provided. Details are listed in the article: haemodynamic and functional consequences of the iatrogenic atrial septal defect following mitraclip therapy.
 
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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 Key11724509
MDR Text Key247273855
Report Number2024168-2021-03505
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K112239
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK SGC01
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 Received06/10/2021
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: 04/26/2021 Patient Sequence Number: 1
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