MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER POST-INFARCT VSD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number 9-VSDMUSCPI-022

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 01/30/2024

Event Type  Death  

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 case study of a 81-year-old patient.It was reported that on an unknown date, a 22mm amplatzer post-infarct muscular vsd occluder was implanted.It was noted the user was unable to get proper device configuration.It was then reported on an unknown date two days post-procedure, the patient passed away due to multi-organ failure.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.[the primary and corresponding author was michal galeczka, medical university of silesia in katowice, silesian centre for heart diseases, 9 curie-sklodowskiej st., 41-800 zabrze, poland, with corresponding email: e-mail: michalgaleczka@gmail.Com].

Manufacturer Narrative

Literature review: "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" b2 - date of death is estimated.B3 - date of event is estimated.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

As 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.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER POST-INFARCT 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: 18791533
• MDR Text Key: 336393928
• Report Number: 2135147-2024-00880
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-VSDMUSCPI-022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• 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): Death
• Patient Age: 81 YR