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

Model Number 9-ASD-MF-035

Device Problem Material Fragmentation (1261)

Event Date 04/05/2014

Event Type  Injury  

Event Description

A 35mm amplatzer cribriform occluder (aco) was used to close a complex atrial septal defect for a patient with platypnea orthodeoxia disorder.The patient still had desaturation issues after device placement.Echo showed the aco to be in good position, but a residual shunt remained.The patient was sent to surgery two days after implant to have the aco removed and the defect closed with a patch.

Event Description

A 35mm amplatzer cribriform occluder (aco) was used to close a patent foramen ovale (pfo) for a patient with platypnea orthodeoxia disorder.At some point post procedure the aco shifted allowing the pfo to open, resulting in desaturation and a persistent right to left shunt.The patient returned to the cath lab where percutaneous retrieval was attempted but the snared aco embolized.The patient was sent to surgery to have the aco removed and the defect closed with a patch.

Manufacturer Narrative

Sjm could not evaluate the aco involved in this incident since it was not returned to us.The device's manufacturing records could not be reviewed since the lot number for the affected product was not provided to st.Jude medical.However, each device is inspected by certified operators to ensure each device is acceptable during manufacturing and prior to shipment.

Manufacturer Narrative

(b)(4).

• Brand Name: AMPLATZER CRIBRIFORM 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: 3761346
• MDR Text Key: 4468105
• Report Number: 2135147-2014-00034
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039/S013
• 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: 04/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-MF-035
• Device Catalogue Number: 9-ASD-MF-035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SNARE
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 59