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

Model Number 9-ASD-010

Device Problem Migration (4003)

Patient Problem Regurgitation (2259)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.

Event Description

It was reported that this was a mitraclip procedure performed to treat degenerative mitral regurgitation (mr) with an mr grade of 4.The xtr clip (91218u121) was implanted at the site of the flailing leaflet.To further reduce mr, the ntr clip (91211u143) was advanced, however after several grasping attempts the clip was removed and was replaced with a second xtr clip.Mr was still 2-3+, thus an attempt to place a 8mm abbott amplatzer septal occluder (aso) (9-asd-008, lot#6732788) in between the two xtr clips was made.Upon release, the device embolized into the descending aorta.After, a second aso (10mm) (9-asd-010, lot#7292821) was prepped and maneuvered into place.Upon release, it too embolized into the descending aorta.The aso strategy was abandoned the aso and another ntr clip was prepped.The ntr was maneuvered into place using the original steerable guide catheter.The clip was implanted and deployed between the previously implanted xtr clips.After many attempts, the 10mm aso device was snared and removed from the patient through the arteriotomy resulting in loss of access.No attempts were made to snare the 8mm aso device.The patient recovered in the recovery area without known incident.A total of three clips were implanted, reducing mr to 3.There were no adverse patient effects related to the clips and there was no clinically significant delay during the procedure.No additional information was provided.

Manufacturer Narrative

Additional information: h6.An event of off-label use of an amplatzer septal occluder to reduce regurgitation and embolization of the device was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined, however the device being used off-label to attempt to close a paravalular leak could have contributed.Please note, per the instruction for use, arten600038247 a , "the amplatzer¿ septal occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the occlusion of atrial septal defects (asd) in secundum position or patients who have undergone a fenestrated fontan procedure and who now require closure of the fenestration.".

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10188517
• MDR Text Key: 201024109
• Report Number: 2135147-2020-00289
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010076
• UDI-Public: 00811806010076
• Combination Product (y/n): N
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ASD-010
• Device Catalogue Number: 9-ASD-010
• Device Lot Number: 7292821
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR
• Patient Weight: 75