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

Catalog Number 9-VSDMUSCPI-024

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 57-year-old patient.It was reported that on an unknown date, a 24mm amplatzer post-infarct muscular vsd occluder was implanted along with an unknown 30mm atrial septal defect occluder to treat ventricular septal rupture (vsr).It was reported there was unstable device position but not confirmed which device.A decision was made to perform vsr surgical closure on an unknown date 15 days post-procedure.The patient was reported to have passed away during vsr surgical closure procedure but cause of death was not confirmed.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 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" b2 - date of death is estimated.B3 - date of event is estimated.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", on an unknown date, a 24mm amplatzer post-infarct muscular vsd occluder was implanted along with an unknown 30mm atrial septal defect occluder to treat ventricular septal rupture (vsr) in a 57-year-old patient.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.Peri- and post-procedural complications included malposition (unstable device position), death, surgical intervention, hospitalization.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: 18792362
• MDR Text Key: 336394302
• Report Number: 2135147-2024-00883
• 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
• 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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-VSDMUSCPI-024
• 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): Death
• Patient Age: 57 YR