MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCC 12MM PKG STER; CARDIAC OCCLUSION DEVICE

Model Number 9-ASD-012

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Embolism (1829); No Code Available (3191)

Event Date 08/08/2014

Event Type  Injury  

Event Description

Transesophageal echocardiogram (tee) confirmed the presence of a small secundum atrial septal defect (asd) measuring 9mm and having adequate rims, except for the aortic rim, which was deficient.The asd was successfully closed using a 12mm amplatzer septal occluder (aso).The position of the aso was found to be optimum and secure on tee and fluoroscopy after the final release.Five minutes after deployment the aso embolized.The aso was surgically removed and the patient is in good condition.

Manufacturer Narrative

(b)(4).The 12mm aso was received at sjm and decontaminated.The aso was grossly and microscopically examined, and no anomalies were found.It met dimensional specifications when measured with a caliper.The aso was loaded into a test 7f loader, deployed and retracted without difficulty or deformation, under non-physiological conditions.The device history record for this product was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.The cause of the embolization during the procedure remains unknown.

• Brand Name: AMPLATZER SEPTAL OCC 12MM PKG STER
• 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: 4055133
• MDR Text Key: 17618873
• Report Number: 2135147-2014-00092
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: PP000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 9-ASD-012
• Device Catalogue Number: 9-ASD-012
• Device Lot Number: 4307407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2013
• 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): Required Intervention
• Patient Age: 16 YR
• Patient Weight: 55