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

Model Number 9-ASD-034

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Embolism (1829)

Event Date 03/18/2014

Event Type  Injury  

Event Description

Despite a minimal ivc rim, a 34mm amplatzer septal occluder (aso) was successfully deployed in the patient.However, later in the icu, the aso embolized to the right atrium.The patient was referred to surgery where the aso was explanted and the defect was surgically repaired.

Manufacturer Narrative

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 results of this investigation are inconclusive because the product was not returned for analysis; however, review of the device history record confirmed the product met manufacturing requirements prior to shipment.The cause of the reported event remains unknown.

Manufacturer Narrative

The 34mm aso was returned to sjm for analysis.The aso contained blood and/or body fluids but no significant tissue.The aso was decontaminated.The occluder was grossly and microscopically examined, and no anomalies were found.The inner and outer sides of the proximal polyester patch contained dark stains, that may have been tissue or body fluids.The occluder met dimensional specifications when measured with a calibrated 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 are inconclusive because the aso tested functional during analysis.The cause of the reported event 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: 3693719
• MDR Text Key: 4254013
• Report Number: 2135147-2014-00027
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/18/2014

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: Physician
• Device Expiration Date: 03/22/2016
• Device Model Number: 9-ASD-034
• Device Lot Number: 1103245026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2014
• Initial Date FDA Received: 03/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2011
• 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: 19 YR
• Patient Weight: 49