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

Model Number 9-ASD-038

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Ventricular Tachycardia (2132); Cardiogenic Shock (2262); Prolapse (2475)

Event Date 12/23/2014

Event Type  Injury  

Event Description

The patient's history was positive for two infarcts and cardiogenic shock at the time a ventricular septal defect closure (vsd) was scheduled.In the medical opinion of the physician, vsd occluders were not suitable and the physician opted to use a 38mm amplatzer septal occluder (aso).At the time of implant, the aso prolapsed into the right ventricle as it was too small for the defect.During the procedure, the patient experienced ventricular tachycardia and required multiple defibrillations and the procedure was aborted.The patient was stabilized.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The device history record 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 38mm aso was returned to sjm and decontaminated.The occluder 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 loader, deployed and retracted without difficulty or deformation, under non-physiological conditions.The results of this investigation confirmed the aso met all functional and dimensional specifications when analyzed at sjm.There was no evidence to suggest there was an intrinsic defect in the occluder, and the cause of the reported prolapse remains unknown.

• 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: 4402484
• MDR Text Key: 16306195
• Report Number: 2135147-2015-00002
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2015
• Device Model Number: 9-ASD-038
• Device Catalogue Number: 9-ASD-038
• Device Lot Number: 1007014569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2010
• 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: 80 YR
• Patient Weight: 72