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

Model Number 9-ASD-018

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Chest Pain (1776); Cardiac Perforation (2513)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

In (b)(6) 2010, a 19 mm amplatzer septal occluder (aso) was deployed in this pediatric patient.Per report, the atrial septal defect had no aortic rim and measured 14 mm x 11 mm.The defect was balloon-sized to 17.5-18.7 mm.Per report, there were two smaller defects 3 mm in size near the central defect.The posterior rim measured over 5 mm.However, the 19 mm aso¿s discs reportedly compressed against the aortic root so the 19 mm aso was removed still attached to the delivery cable.Next, a 17 mm aso was attempted; however, during the wiggle test the rims prevented the aso from being placed so the 17 mm aso was removed still attached to the delivery cable.An 18 mm aso was selected and implanted without issue.On (b)(6) 2016, the patient experienced chest pain and was admitted.On (b)(6) 2016, a transthoracic echo (tte) revealed a 2.5 mm pericardial effusion and 250 ml of blood was removed via pericardiocentesis and the patient was urgently transferred to another hospital at which time the aso was surgically removed and the atrial septal defect was repaired using a patch.Prior to explant, the tte revealed abnormal flow around the transverse sinus on the aorta side of the disks.Per report, the left atrial roof was suspected to have eroded; however, the actual erosion site was located at the inner surface of the left disc, not the device edge.On (b)(6) 2016, the patient was discharged from the hospital in stable condition.

Manufacturer Narrative

(b)(4).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

This event was reviewed by the st.Jude medical erosion board and 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: 6187249
• MDR Text Key: 62798931
• Report Number: 2135147-2016-00128
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• 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
• Date Manufacturer Received: 12/05/2016
• 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: 14 YR