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

Model Number	9-ASD-026
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erosion (1750); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	07/17/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
An event of erosion, pericardial effusion, tamponade and patient death was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the warnings section of the instructions for use (arten600039487), "patients with a retro-aortic rim of less than 5 mm in any echocardiographic plane, or patients in whom the device physically impinges on (i.E.Indents or distorts) the aortic root, may be at increased risk of erosion." "absence of the anterior superior (aortic) rim and device oversizing may be related to the causation of erosion due to the increased likelihood of device-tissue contact in the dynamic anatomic area at highest risk for erosion.".
Event or Problem Description
On (b)(6) 2018, a 26 mm amplatzer septal occluder was implanted.After implant, the patient complained of chest pain and echocardiogram showed a small to moderate pericardial effusion with the device still in good position.Bedside pericardiocentesis was performed and the patient was intubated.The pericardiocentesis revealed frank blood clots and the patient quickly decompensate and cpr was administrated.The patient required cpr while transferred to the or where an emergency sternotomy was performed.The patient was placed on cardiac bypass, and cardiac tamponade physiology was noted.In the operating room (or), two holes were demonstrated in the aortic root and roof of the right atrium.Both were surgically closed.Due to the clinical condition the patient was transferred to a regional medical center for ecmo.Upon arrival at the second hospital on (b)(6) 2018, the patient was taken to the or where the device was noted to be in good position however the disk had left an indentation in the atria and had rubbed through the roof of the atria at the junction of the aortic roof and right atria.The device was removed.The patient¿s heart slowly recovered with the use of ecmo, however the head and abdominal ct showed the patient had insurmountable injuries and care was withdrawn.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: CARDIAC OCCLUSION DEVICE
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7780735
• Report Number: 2135147-2018-00101
• Device Sequence Number: 1392328
• Product Code: MLV
• UDI-Device Identifier: 05415067019318
• UDI-Public: 05415067019318
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 9-ASD-026
• Device Catalogue Number: 9-ASD-026
• Device Lot Number: 5570863
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 15 YR