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

Model Number 9-ASD-013

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Unstable (1667)

Patient Problem Embolism (1829)

Event Date 06/27/2014

Event Type  No Answer Provided  

Event Description

A 13mm amplatzer septal occluder (aso) was deployed but it was not stable at the defect.The aso was already detached from the delivery cable so a snare catheter and a 9f amplatzer 45 exchange system (aes45) were used to remove the aso; however, during the retrieval process the aso became loose from the retrieval device and embolized into the left atrium.The 9f aes45 was exchanged for a 12f aes45 and the aso was removed.Next, a 14mm aso deployed cobra-shaped.When a second 14mm aso was attempted, the patient was deemed not suitable for percutaneous closure and the procedure was aborted.

Manufacturer Narrative

The 13mm aso was not returned to sjm for analysis.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.

• 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 ; 6517565400
• MDR Report Key: 3926999
• MDR Text Key: 4669597
• Report Number: 2135147-2014-00067
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000039
• 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
• Report Date: 06/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/11/2017
• Device Model Number: 9-ASD-013
• Device Lot Number: 1211079556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2012
• 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: 4 YR
• Patient Weight: 14