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

Model Number 9-ASD-018

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Type  Injury  

Manufacturer Narrative

Udi: unknown since the lot number is unknown.

Event Description

The information was obtained from the following literature article: arnaz a.Et al, "late cardiac rupture after amplatzer septal occluder implantation." tex heart inst j.2016 dec 1;43(6):541-542.In 2012, a (b)(6)-year-old woman underwent percutaneous closure of an atrial septal defect and a 18 mm amplatzer septal occluder (aso) was implanted.She was discharged on the first postoperative day with no sequelae, as confirmed by transthoracic echocardiography (tte).In (b)(6) 2013, the patient was admitted to the emergency department with sudden-onset dyspnea and subsequent syncope.Tte revealed dense pericardial effusion, fibrin, and cardiac tamponade.The patient, in shock, underwent urgent operation.Intraoperative examination revealed rupture of the left atrial roof and noncoronary aortic sinus, caused by an the aso.A temporary pledgeted suture on the ruptured noncoronary sinus of the ascending aorta was placed to stop the bleeding.The aso was then removed, and a temporary autologous pericardial patch was constructed for the ostial secundum asd.Finally, the left atrial and noncoronary aortic sinus walls were primarily repaired.The patient was extubated on the first postoperative day, and no neurologic or other major sequelae were seen.She was discharged on the fifth postoperative day in a good overall condition.Patient identifier and weight are not available.

Manufacturer Narrative

An event of "rupture of the left atrial roof and noncoronary aortic sinus" was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

Please note: it was determined that this event is a duplicate event of one that was already submitted under (b)(4).

• 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: 7135853
• MDR Text Key: 95454386
• Report Number: 2135147-2017-00185
• 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,Followup
• Report Date: 01/19/2018

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
• 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: 11/21/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 12/20/2017; 12/26/2017
• Supplement Dates FDA Received: 01/16/2018; 01/19/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 22 YR