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

Model Number	9-ASD-026
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erosion (1750); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	11/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Events of erosion, pericardial effusion, and cardiac perfusion were 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. .
Event or Problem Description
On (b)(6) 2017, a 26mm amplatzer septal occluder was implanted in a patient with a large asd measuring 22-24mm on tee.Tee showed the device was in excellent position and no pericardial effusion was observed.The patient was discharged the following day.Tee from two follow-up visits had no significant findings.On (b)(6) 2018, the patient collapsed and was transported to the emergency room.The patient had been complaining of chest pain one week prior.At the er, echocardiogram showed a large pericardial effusion and erosion resulting in acute hemopericardium and hypotension.An emergent pericardiocentesis was performed where 300cc of blood was drained.Following drainage, the patient's blood pressure increased from 70/40 to 130/80 and their heart rate decreased.The patient was transferred to the operating room where a 6mm by 3mm perforation was observed in the dome of the left atrium and a 2 by 3mm perforation was seen in the non-coronary sinus.The device was removed and a pericardial patch closure was performed.During recovery, the patient was taken back to the or to remove a large clot in the pericardium compressing the left atrium.The patient was reported to be recovered without event and sustaining no neurological injury.(voluntary medwatch reference number: mw5082067).

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8292381
• Report Number: 2135147-2019-00030
• Device Sequence Number: 19241898
• Product Code: MLV
• UDI-Device Identifier: 05415067019318
• UDI-Public: 05415067019318
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2019

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: 09/30/2020
• Device Model Number: 9-ASD-026
• Device Catalogue Number: 9-ASD-026
• Device Lot Number: 5275310
• 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: 01/08/2019
• Initial Report FDA Received Date: 01/31/2019
• 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: Required Intervention