MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number CVD0091

Device Problem Biocompatibility (2886)

Patient Problem Arrhythmia (1721)

Event Type  Injury  

Manufacturer Narrative

Further information will be provided in a subsequent report to address pi closure.

Event Description

It was reported through a research article identifying the amplatzer septal occluder may be related to an adverse event.Details are listed in the attached article, titled "amplatzer septal occluder-induced transient complete atrioventricular block." event summary: on an unknown date a (b)(6)-year-old boy presented with complete atrioventricular block after undergoing percutaneous closure of a large secundum asd with an amplatzer septal occluder.Pre-procedure, the ecg showed a normal sinus rhythm with incomplete right bundle branch block and also had a pre-procedure, tee which confirmed a 2.74-cm secundum asd.The asd was measured by echocardiogram at 23 mm, and at 25mm by amplatzer balloon sizing.The decision was made to implant a 28-mm aso.The left atrial disc was deployed in the left atrium and the waist in the defect itself.The right atrial disc was then deployed in the right atrium.Although the aso, with the delivery cable was still in place, it was determined to be in the proper position, the ecg showed cavb with an accelerated junctional rhythm of 80 bpm.The aso was retrieved at this time and the normal sinus rhythm returned.However, cavb recurred after redeployment of the device.Although the right atrial disc of the aso was seen to be touching the septal annulus of the tricuspid valve after occlusion, there was no significant tricuspid valve stenosis or insufficiency present.The user indicates the mechanism causing conduction defects and rhythm disturbance after aso implantation is unclear, it is reasonable to hypothesize that it relates to the proximity of the device to the av node.

Manufacturer Narrative

Additional information g4, h2, h3, h6, h10.As reported in a research article, during implant of an amplatzer septal occluder the patient experienced cavb with an accelerated junctional rhythm when the device was depolyed.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined, however the field hypothesized that it was due to the closeness of the device to the av node.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9987151
• MDR Text Key: 188903020
• Report Number: 2135147-2020-00177
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

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 Model Number: CVD0091
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 05/02/2020
• Supplement Dates FDA Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 YR
• Patient Weight: 21