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

Model Number 9-ASD-008

Device Problems Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, an amplatzer septal occluder was implanted in a premature infant and the occluder migrated; the device was snared and redeployed.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the amplatzer septal occluder instructions for use, artmt600034288 revision c "warnings: the device is sterilized using ethylene oxide and is for single use only.Do not reuse or resterilize.Attempts to resterilize the device may result in device malfunction, inadequate sterilization, or patient harm.".

Event Description

The article "hybrid placement and subsequent successful hybrid repositioning of unbuttoned amplatzer septal occluder through mini- anterior-thoracotomy in a premature infant" published on 29 september 2020 was reviewed.It was reported that a (b)(6) female was implanted with an 8mm amplatzer septal occluder.Two days post procedure, the occluder was observed to have migrated under trans thoracic echo (tte).The device was snared and pulled back, then redeployed across the atrial septum.At 3 months follow up, the device was well seated without any residual shunt.The article concluded that dual-chamber pacing may have the potential to become one of the non-surgical therapeutic options for those with post-surgical residual subvalvular gradient, not only for severe aortic stenosis and subvalvular obstruction but also for obstructive hypertrophic cardiomyopathy.The primary author of the article is , department of medicine, chikamori hospital, kochi, japan.The article concluded that that hybrid recapture and repositioning of displaced amplatzer atrial septal occluder in an infant through anterior mini-thoracotomy may be considered in small infants with limited access when surgical cardiopulmonary needs to be avoided.The primary author of the article is rupesh natarajan, md of division of pediatric cardiology, department of pediatrics, university of minnesota masonic children's hospital.The corresponding author is g.Hiremath, of md of division of pediatric cardiology, department of pediatrics, university of minnesota masonic children's hospital, with the corresponding email of hiremath@umn.Edu.

• Brand Name: AMPLATZER SEPTAL 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: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10862128
• MDR Text Key: 216933665
• Report Number: 2135147-2020-00485
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-008
• Device Catalogue Number: 9-ASD-008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2020
• 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): Required Intervention
• Patient Age: 4 MO