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

Catalog Number UNK AMPLATZER SEPTAL OCCLUDER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Myocardial Infarction (1969)

Event Date 11/22/2022

Event Type  Injury  

Event Description

The article, "giant right coronary artery pseudoaneurysm exclusion with atrial septal defect closure device following coronary rupture" was reviewed.It was reported that on an unknown date, an unknown size amplatzer septal occluder was chosen for implant.Two months prior to the occluder implant, the patient presented with inferior st-segment elevation myocardial infarction.A coronary angiography was performed and revealed an ostial right coronary in-stent thrombotic occlusion.A 3.5mm balloon was used to perform high pressure expansion.A whole-body 18f-fluorodeoxyglucose positron emission tomography¿computed tomography (ct) was completed, which demonstrated intense glucose metabolism surrounding the drug-eluting stent implanted in the proximal right coronary artery.Two months later an additional ct scan was performed that showed an ostial coronary rupture occurred, along with giant mediastinal pseudoaneurysm compressing the right heart chambers.Additional ct scans demonstrated a complete fracture of the implanted coronary stent with malalignment and a gap bigger than 20mm, corresponding to an infected stent.The team decided to use an amplatzer septal occluder to perform a percutaneous exclusion of the pseudoaneurysm.The occluder was successfully placed in the ostial right coronary artery position via femoral access.24 hours post implant, the patient developed a right ventricular infarction requiring fluid resuscitation and amines support with favorable evolution.The patient was discharged 10 days later.Three months after the procedure, coronary ct angiography demonstrated total exclusion associated with thrombosis and regression of the pseudoaneurysm.At 7 months¿ follow-up, the patient was symptom-free without complications.No additional information was provided.The primary author of the article is radu spînu, md.The correspondence author of the article is dr radu spînu, cardiology department, hospital of annecy, 1 avenue de l¿hopital, epagny metz-tessy 74370, france.With the corresponding e-mail: raduspin@gmail.Com.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

An event of right ventricular infarction 24 hours after the device was implanted in a pseudoaneurysm was reported from a literature article.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or additional patient information was received for analysis.Based on the available information, the root cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Please note, per the most recent instructions for use " the amplatzer¿ septal occluder is a percutaneous, transcatheter atrial septal defect closure device intended for the occlusion of atrial septal defects (asds) in secundum position or patients who have undergone a fenestrated fontan procedure and who now require closure of the fenestration.".

• 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 Key: 16127109
• MDR Text Key: 306984708
• Report Number: 2135147-2023-00117
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER SEPTAL OCCLUDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2023
• 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): Required Intervention