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

Model Number 9-ASD-015

Device Problem Extrusion (2934)

Patient Problems Erosion (1750); Tachycardia (2095); Cardiac Tamponade (2226); No Code Available (3191); Pericardial Effusion (3271)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A patient with a complex medical history was implanted with a 15mm amplatzer septal occluder (aso) on (b)(6) 2015 secondary to increasing dyspnea and hypoxemia.Pre-implant, the defect was balloon-sized to 14mm before "stop flow" was achieved.Follow-up echo on (b)(6) 2015, looked satisfactory.On (b)(6) the patient presented to the emergency room with presyncopal episodes and tachycardia at which point a ct diagnosed a pericardial effusion.The patient was transferred to (b)(6) where a tte confirmed the effusion and the patient was sent to surgery.Cardiac tamponade was present and pericardiocentesis was performed with approximately 200ml of sanguineous fluid removed.The aso was explanted and the erosion to the atrial roof was repaired, along with a patch closure asd was performed.

Manufacturer Narrative

(b)(4).The results of this investigation concluded the aso was covered in a mucus-like material that made gross, dimensional, and functional analysis difficult.A review of the device history record confirmed the occluder met all visual, dimensional, and functional specifications at the time it was manufactured, prior to shipment.There was no evidence to suggest there was an intrinsic defect, as supported by review of the valve's device history record.The cause of the reported event remains unknown.The event was reviewed by the sjm erosion board who 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: 5168355
• MDR Text Key: 28936452
• Report Number: 2135147-2015-00128
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/31/2017
• Device Model Number: 9-ASD-015
• Device Catalogue Number: 9-ASD-015
• Device Lot Number: 1209072525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2012
• 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: 32 YR
• Patient Weight: 22