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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

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ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER Back to Search Results
Catalog Number UNK AMPLATZER SEPTAL OCCLUDER
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 01/01/2001
Event Type  Death  
Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature: article title: "impact of atrial septal defect closure on mortality in older patients".
 
Event Description
The article, "impact of atrial septal defect closure on mortality in older patients", was reviewed.The article presented a retrospective, single center to evaluate the mortality rates in older atrial septal defect (asd) patients with and without closure.Devices included in this study were cocoon and amplatzer septal occluder devices.The article concluded that asd closure demonstrated favorable outcomes in older patients.Age, nyha class, blood urea nitrogen (bun), right ventricular systolic pressure (rvsp), and asd closure were identified as independent factors linked to mortality in this population.[the primary and corresponding author was nithima ratanasit, mahidol university, 999 phutthamonthon sai 4 rd, salaya, phutthamonthon district, nakhon pathom 73170, thailand, with corresponding email: nithma.Rat@hotmail.Com] the time frame of the study was from 01 january 2001 to 31 january 2017.A total of 299 patients who received asd closure were included, of which it could not be confirmed how many received an abbott device.The average age was 55.1 years and the majority gender was female.Comorbidities included hypertension, hyperlipidemia, diabetes mellitus, stroke, coronary artery disease, atrial fibrillation, history of heart failure.
 
Manufacturer Narrative
Summarized patient outcomes/complications of impact of atrial septal defect closure on mortality in older patients were reported in a research article in a subject population with multiple co-morbidities including hypertension, hyperlipidemia, diabetes mellitus, stroke, coronary artery disease, atrial fibrillation, history of heart failure.Some of the complications reported was death this complication is anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.¿literature attachment: article title: impact of atrial septal defect closure on mortality in older patients.¿.
 
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Brand Name
AMPLATZER SEPTAL OCCLUDER
Type of Device
TRANSCATHETER SEPTAL OCCLUDER
Manufacturer (Section D)
ABBOTT MEDICAL
5050 nathan lane n
plymouth MN 55442
Manufacturer (Section G)
ABBOTT MEDICAL REG# 2135147
5050 nathan ln n
plymouth MN 55442
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key19013989
MDR Text Key339060836
Report Number2135147-2024-01428
Device Sequence Number1
Product Code MLV
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
P000039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK AMPLATZER SEPTAL OCCLUDER
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/07/2024
Initial Date FDA Received04/01/2024
Supplement Dates Manufacturer Received04/15/2024
Supplement Dates FDA Received04/24/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
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