MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER PFO OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-PFO-035

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 01/09/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, two pfo occluders (pfo) and an amplatzer atrial septal occluder (aso) were selected for implant.A 25mm pfo occluder was deployed in the septum, but quickly prolapsed into the right atrium while attached to the delivery cable.The device was removed and a 35mm pfo occluder was deployed and released.Ice observed the left atrial disc partially prolapsed into right atrium at aorta.Within approximately 3 minutes, the 35mm pfo occluder was found to have embolized into the right ventricle.A 24mm sizing balloon was used to sized the pfo defect.The balloon sizing on fluoroscopy was 23.9mm and by ice was 24.2mm.The physician decided to implant a 26mm aso through a 12 french delivery system.The 26mm aso device was seated well and no color flow was evident through or around device.A 35mm snare was used to secure the 35mm pfo occluder in the right ventricular outflow tract.A second 35mm snare was utilized to capture the female thread post of the occluder unsuccessfully.The 2nd snare also wrapped around the connecting waist of the occluder.A 20mm snare was then advanced through a large bore sheath, captured the female thread post of the 35mm pfo occluder, withdrew the device into the sheath and removed from body.The patient experienced episodes of desaturation with pulse oximetry as low as 40%.The patient was transferred to critical care area and placed on ecmo for continuous low saturations.On the following day, (b)(6) 2019, a ct was obtained and ruled out pulmonary embolism.While the patient was given a continuous iv infusion, tee observed saline (microbubbles) crossing the atrial septum slowly and abundantly apparently through the 26mm aso occluder.After much consideration, the patient was referred for surgical removal of 26mm aso and repair of septum with patch.The patient was subsequently removed from ecmo with satisfactory results.

Manufacturer Narrative

An event of embolization was reported.The investigation confirmed the device met functional and dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• 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: 8301638
• MDR Text Key: 134887804
• Report Number: 2135147-2019-00037
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011301
• UDI-Public: 00811806011301
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 9-PFO-035
• Device Catalogue Number: 9-PFO-035
• Device Lot Number: 5741658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2016
• 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
• Patient Age: 64 YR