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

Model Number 9-PFO-030

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a 30mm amplatzer patent foramen occluder was selected for use.The device's left atrial disc deployed in a balloon-like form within the patient.The device was resheathed and replaced with a 35mm amplatzer patent foramen occluder which was successfully implanted.The patient remained hemodynamically stable throughout the procedure and did not have any adverse health consequences.The procedure was not significantly extended.Patient's information (e.G.Age, weight, gender, ethnicity, race, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.

Manufacturer Narrative

The reported event of deformity upon deployment could not be confirmed.The investigation confirmed the device met functional specifications when analyzed at abbott under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

• Brand Name: AMPLATZER PFO 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7879568
• MDR Text Key: 120381774
• Report Number: 2135147-2018-00153
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2018

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: 10/31/2022
• Device Model Number: 9-PFO-030
• Device Catalogue Number: 9-PFO-030
• Device Lot Number: 6222927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 10/11/2018
• Supplement Dates FDA Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2017
• 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): Hospitalization; Required Intervention