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

Model Number 9-ASD-007

Device Problem Positioning Problem (3009)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 06/05/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, this 7 mm amplatzer septal occluder (aso) was implanted in a patient who was very unstable due to reactive pulmonary hypertension (pht) and frequent crisis.During catheterization, upon crossing the interatrial septum (ias), the patient had a pht crisis despite sedation.The aso was deployed, but settled perpendicular on the ias.The physician was unable to confirm if the device was stable and adequate in the procedure suite.During echo evaluation, post pht crisis which impeded pa flow, the device was found to be embolized.The patient was referred for surgery which was performed on (b)(6) 2015.The patient's status was reported to be good.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The results of this investigation confirmed the amplatzer septal occluder met all functional and dimensional specifications when analyzed at sjm.A review of the device history record confirmed the occluder met all visual, dimensional, and functional specifications at the time it was manufactured, prior to shipment.There was no evidence to suggest there was an intrinsic defect in the occluder, and the cause for the embolization 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: 4888650
• MDR Text Key: 6071524
• Report Number: 2135147-2015-00068
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2015

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: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 9-ASD-007
• Device Catalogue Number: 9-ASD-007
• Device Lot Number: 4943830
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 1 YR
• Patient Weight: 5