MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-ASD-010

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Foreign Body Embolism (4439)

Event Date 08/11/2021

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported that on (b)(6) 2021, a 10 mm amplatzer septal occluder was chosen for closure on an atrial septal defect (asd).The defect was measured to be 7mm by 9-10mm via 3d echocardiography.After the device was deployed into the defect, a push/pull test was performed to check for stability, which showed the device to be secure, and then the device was released.After leaving the procedure room, an x-ray was performed which showed that the device had embolized to the main pulmonary artery (pa) with obstruction.The patient was eating at the time, so retrieval could not occur until later that day.Imaging performed prior to device retrieval showed that the device had moved to the aorta.The device was successfully retrieved via transcatheter snare.A 12 mm amplatzer septal occluder was then implanted without complications to resolve this event.The patient remained hemodynamically stable throughout both procedures.The patient did not experience any permanent impairment or damage as a result of this event.The patient did not experience any other adverse event or symptoms.No additional information was provided.

Manufacturer Narrative

An event of "the device had embolized to the main pulmonary artery (pa) with obstruction" 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.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12384067
• MDR Text Key: 268676956
• Report Number: 2135147-2021-00344
• Device Sequence Number: 1
• Product Code: MLV
• 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: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR