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

Model Number 9-ASD-009

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Dyspnea (1816); Embolism (1829); Tachycardia (2095)

Event Date 04/21/2015

Event Type  Injury  

Event Description

The atrial septal defect measured 6.2mm in length via tee.Initially, a 7mm amplatzer septal occluder (aso) was attempted but after it fell into the defect and into the left atrium, the 7mm aso was removed as it remained attached to the delivery cable.Next, a 9mm aso was successfully deployed without issue.Five and a half hours post-procedure, the patient became dyspneic and had sinus tachycardia.The patient was diagnosed with hyperventilation syndrome and the patient improved with breathing maneuvers, returning her to a normal heart rate.An angiography then revealed the aso had embolized to the left common iliac artery.A 12f sheath was delivered via the left femoral artery and the 9mm aso was percutaneously removed using a gooseneck snare.The patient was discharged without any complications.The physician may reattempt percutaneous closure in the future.

Manufacturer Narrative

(b)(4).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 results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 4803090
• MDR Text Key: 21842319
• Report Number: 2135147-2015-00054
• 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: 05/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/31/2019
• Device Model Number: 9-ASD-009
• Device Catalogue Number: 9-ASD-009
• Device Lot Number: 4680787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2014
• 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