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

Catalog Number UNKAMPLATZERMUSCULARVSDOCCLUD

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problems Hemolysis (1886); Thrombosis/Thrombus (4440); Tricuspid Valve Insufficiency/ Regurgitation (4453); Unspecified Tissue Injury (4559)

Event Date 01/01/2000

Event Type  Injury  

Manufacturer Narrative

Literature article: "multicentre short- and medium-term report on the device closure of a post-myocardial infarction ventricular septal rupture ¿ in search of risk factors for early mortality" summarized patient outcomes/complications of a multi-center study to find early mortality (<30 days) risk factors of device ventricular septal rupture (vsr) closure were reported in a research article "multicentre short- and medium-term report on the device closure of a post-myocardial infarction ventricular septal rupture ¿ in search of risk factors for early mortality" in a subject population with multiple co-morbidities including arterial hypertension, hypocholesterolemia, nicotinism, diabetes, atrial fibrillation, significant mitral insufficiency, prior stroke, chronic kidney disease, significant aortic stenosis, prior myocardial infarction, clinical states included: inotropes, cardiogenic shock, need for intra-aortic balloon pump, and elevated creatinine.Some of the complications reported were death, surgical intervention, unexpected medical intervention, hospitalization, hemolysis, mesenteric artery thrombosis, tricuspid regurgitation, tricuspid valve damage (unspecified tissue damage), residual shunt, device embolization; these complications are 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.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

The article, "multicentre short- and medium-term report on the device closure of a post-myocardial infarction ventricular septal rupture ¿ in search of risk factors for early mortality", was reviewed.The article presented a retrospective, multi-center study to find early mortality (<30 days) risk factors of device ventricular septal rupture (vsr) closure and to evaluate its medium-term outcome.Devices included in this study were amplatzer septal occluder, amplatzer multi-fenestrated septal occluder - cribriform, cardi-o-fix atrial septal occluder, lifetech atrial septal occluder, amplatzer post-infarct muscular ventricular septal defect (vsd) occluder, amplatzer muscular vsd occluder, lifetech muscular vsd occluder, and occlutech muscular vsd occluder.The article concluded that procedure of vsr device closure demonstrates an acceptable technical success rate; however, the incidence of severe complications and early mortality is notably high.Older patients in poor hemodynamic condition and those with unsuccessful occluder deployment are particularly at a higher risk of a fatal outcome.The prognosis after early survival is promising.(b)(6).The time frame of the study was from 2000 to 2020.A total of (b)(4) patients were included in this study, of which (b)(4) of devices were abbott.The average age was 67 years, the average weight was 73.5 kg, and the average gender was male.Comorbidities included arterial hypertension, hypocholesterolemia, nicotinism, diabetes, atrial fibrillation, significant mitral insufficiency, prior stroke, chronic kidney disease, significant aortic stenosis, prior myocardial infarction, clinical states included: inotropes, cardiogenic shock, need for intra-aortic balloon pump, and elevated creatinine.

• Brand Name: AMPLATZER MUSCULAR VSD 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 Key: 18789567
• MDR Text Key: 336395917
• Report Number: 2135147-2024-00867
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P040040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAMPLATZERMUSCULARVSDOCCLUD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention