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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 Dyspnea (1816); Edema (1820); High Blood Pressure/ Hypertension (1908); Pulmonary Edema (2020); Tricuspid Regurgitation (2112); Heart Failure (2206); Atrial Perforation (2511)
Event Date 06/01/2015
Event Type  Injury  
Manufacturer Narrative
Date of event: date estimated. The udi number is not known as the part and lot number were not provided. The device was not returned for analysis and a review of the lot history record could not be performed as the lot information regarding the complaint device was not provided. Based on the information reviewed and due to the limited information available from the article, a cause for the reported heart failure, atrial perforation, edema, tricuspid regurgitation, pulmonary edema, hypertension, and dyspnea cannot be determined. However, heart failure, atrial perforation, edema/pulmonary edema, hypertension, and dyspnea are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures. The reported additional therapy/non-surgical treatment and hospitalization were a result of case-specific circumstances. There is no indication of a product issue with respect to manufacture, design or labeling. Literature. Article title ¿biventricular physiology of iatrogenic atrial septal defects following transcatheter mitral valve edge-to-edge repair.
 
Event Description
This is filed to report heart failure, hypertension, edema, atrial perforation, pulmonary edema, worsening tricuspid regurgitation, medical intervention, and prolonged hospitalization,. It was reported through a research article identifying steerable guide catheters that were related to the following outcomes: heart failure, dyspnea, hypertension, edema, atrial perforation, pulmonary edema, worsening tricuspid regurgitation, medical intervention, prolonged hospitalization, and death. Specific patient information is documented as unknown. Details are listed in the article, titled, "biventricular physiology of iatrogenic atrial septal defects following transcatheter mitral valve edge-to-edge repair. ¿ 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 Key11309870
MDR Text Key231372768
Report Number2024168-2021-01074
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 literature
Reporter Occupation
Type of Report Initial
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
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 Received01/21/2021
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: 02/10/2021 Patient Sequence Number: 1
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