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

Catalog Number 9-ASD-028

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2023, a 28mm amplatzer septal occluder was chosen for an atrial septal defect (asd) closure procedure using an unknown delivery system.The occluder was successfully deployed in the left ventricle.On an unknown date, it was noted that the device was migrated.The device was taken out surgically and the asd was closed in an open heart surgery.

Manufacturer Narrative

An event of device embolization into the left atrium, left ventricle and explant was reported.Information from the field indicated that the defect was sized using a transesophageal echocardiogram and x-ray imaging.A returned device 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.

Event Description

It was reported that on (b)(6) 2023, a 28mm amplatzer septal occluder was chosen for an atrial septal defect (asd) closure procedure using a 10f amplatzer trevisio intravascular delivery system.The defect was measured in transesophageal echocardiogram (tee) and x-ray imaging.During procedure, the device was implanted and then dislodged completely from the implant site to the left ventricle before the transesophageal echocardiogram (tee) probe was removed.The device travelled to the left ventricle and then back into the left atrium.After the retraction attempts, the device went into the left ventricle again.The device was explanted in an emergency open heart surgery, and the asd was also closed during the surgery.The physician mentioned that the cause of embolization was the tissue might have been too soft in order to hold the device.The patient was reported discharged.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18322873
• MDR Text Key: 330428714
• Report Number: 2135147-2023-05497
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010212
• UDI-Public: 00811806010212
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ASD-028
• Device Lot Number: 8728331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• 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; Life Threatening