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

Model Number 9-ASD-010

Device Problem Unintended Movement (3026)

Patient Problem Regurgitation (2259)

Event Type  Injury  

Manufacturer Narrative

Udi: unknown since the lot number is unknown.

Event Description

The following information was obtained from the following literature article: manolis as."percutaneous retrieval of a dislodged amplatzer septal occluder device from the pulmonary artery with sole use of a snare and device lassoing." hellenic j cardiol.2017 aug 14.This article reports a case study of a (b)(6) woman who was belatedly diagnosed with a large secundum asd after she had been complaining of dyspnea on exertion, fatigability, and migrainous headaches for a long time.During the initial procedure (date unknown), the asd diameter was calculated at 22.8 mm with the use of balloon sizing, and a 24 mm amplatzer septal occluder (aso) was chosen for implantation.Although initially, there was apparent sealing of the defect and improvement in symptomatology, at the 6-month tee re-evaluation, the patient showed residual left-to-right shunting, and the decision was made to implant a second device.A 10 mm aso was selected and initially placed uneventfully, indicating no residual left-to-right shunting.Fifteen minutes later, fluoroscopy revealed the 10 mm aso had migrated into the right pulmonary artery.The patient had no symptoms at this point.A decision was made to attempt to re-capture and extract the device by percutaneous means.A snare loop was manipulated and managed to capture the device at the screw of the right disc and pull it to the main pulmonary artery.Re-arrangement of the loop was required at this stage due to device slippage, and after re-grasping the device at the waist, the aso was successfully pulled down to the iliofemoral vessels and finally extracted from the left groin area by using forceps to pave the way through the subcutaneous tissue.Due to a prolonged and complicated procedure, no attempt was made during this procedure to re-implant a larger device, and the patient was offered the option of a repeat percutaneous procedure or a surgical approach in the future.Three months later, the patient opted for elective surgery that was successfully carried out.In conclusion, percutaneous retrieval of an embolized aso from the right pulmonary artery was performed with sole use of a snare by lassoing the aso at its waist, thereby obviating open heart surgery in an asd patient undergoing a second percutaneous procedure for additional device implantation for residual shunting.(b)(4) is for the 9-asd-024 device and this mdr ((b)(4)) is for the 9-asd-010 device.

Manufacturer Narrative

An event of embolization was reported.The results of the investigation are inconclusive since the device was not returned for analysis.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: 7134162
• MDR Text Key: 95366920
• Report Number: 2135147-2017-00181
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: P000039
• 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: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-010
• Device Catalogue Number: 9-ASD-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR