MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number 9-ASD-018

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Erosion (1750); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Type  Injury  

Manufacturer Narrative

Udi: unknown as lot/serial numbers are unknown.The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

According to the article titled, late cardiac rupture after amplatzer septal occluder implantation, transcatheter device implantation has become an attractive alternative to surgery in the closure of atrial septal defects in selected patients.According to the article, it can lead to early and late sequelae, some of them life threatening.In one case, a patient implanted with an 18mm amplatzer septal occluder (aso) 79 days earlier was admitted to the emergency department in (b)(6) 2013 with sudden-onset respiratory distress and respiratory arrest (leading to cardiac tamponade and rupture).In the initial examination, the patient was unconscious and in respiratory arrest.Following cpr, the patient was intubated.Transthoracic echocardiography revealed dense pericardial effusion, fibrin, and cardiac tamponade.The patient, in shock, was sent to surgery.Intraoperative examination revealed a rupture of the left atrial roof and noncoronary aortic sinus, reportedly caused by the aso.A temporary pledgeted suture was placed on the ruptured noncoronary sinus of the ascending aorta, to stop the bleeding through a very small perforation.After a standard bicaval cannulation, bypass was initiated.The aso was removed, and a temporary autologous pericardial patch was constructed.The patient was discharged five days post-operatively.The article warned that patients who have a short anterosuperior rim and are implanted with an oversized aso are at higher risk of device erosion as the edge of the device adjacent to the superior rim moves like a seesaw during each cardiac cycle, thereby straining the right or left atrial free wall, or the atrial roof towards the septum.The edge of the device erodes the atrial wall and eventually erodes the adjacent aortic sinus, rupturing the aorta.(doi.Org/10.14503/thij-15-5635).

Event Description

This event was reviewed by the abbott erosion board which confirmed that erosion occurred.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6335206
• MDR Text Key: 67546098
• Report Number: 2135147-2017-00022
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/29/2017

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: 9-ASD-018
• Device Catalogue Number: 9-ASD-018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2017
• 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
• Patient Age: 22 YR