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

Model Number	9-ASD-013
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	07/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, an 8 fr amplatzer torqvue 45 delivery system (lot.6298737) was used to implant a 13 mm amplatzer atrial septal occluder in a pediatric patient.The procedure was without event.On (b)(6) 2018, the patient fell and took a hit to the chest.Following that the patient started to feel chest pain and was referred to a local hospital where the implant had not occurred.A pericardial effusion was seen at tte and the patient underwent cardiac surgery on (b)(6) 2018.A perforation of the roof of the left atrium was found.The device was removed and the defect was closed with a bovine pericardial patch.The patient was reported in good condition and stable.Per report from the user the cause of this event is unknown.
Additional Manufacturer Narrative
Event description: added sentence " echo and implant / implant op reports were requested, but not provided by the hospital or physician " an event of pericardial effusion was reported.The investigation confirmed the device met all dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown, however, information from the field indicated that the pericardial effusion was observed after the patient fell and sustained an impact hit to the chest.
Event or Problem Description
On (b)(6) 2018, a 13mm amplatzer atrial septal occluder was successfully implanted in a pediatric patient at a hospital in bologna.An 8 fr amplatzer torqvue 45 delivery system (lot.6298737) was used for delivery.On (b)(6) 2018, the patient fell and sustained an impact hit to the chest.The patient started to experience chest pain and was referred to another hospital in (b)(6).A pericardial effusion was seen at tte and the patient underwent cardiac surgery on (b)(6) 2018.A perforation of the roof of the left atrium was found.The device was removed and the defect was closed with a bovine pericardium patch.The patient was reported in good condition and stable.Per report, cause of this event is unknown.Additional records, including echocardiogram and procedure reports were requested, but not provided by the hospital or physician.

• 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: 7772151
• Report Number: 2135147-2018-00098
• Device Sequence Number: 13800854
• Product Code: MLV
• UDI-Device Identifier: 00811806010106
• UDI-Public: 00811806010106
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2018

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: 05/31/2022
• Device Model Number: 9-ASD-013
• Device Catalogue Number: 9-ASD-013
• Device Lot Number: 6043147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 08/30/2018
• 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: Hospitalization; Required Intervention