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

Model Number SEPTAL OCCLUDER

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Mitral Perforation (2512); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 06/30/2022

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) 2022, a 19mm amplatzer septal occluder (aso) was implanted using a 9f amplatzer trevisio intravascular delivery system.The aso had been sized using a 24mm amplatzer sizing balloon and ice examination it was confirmed via intracardiac echocardiography (ice) that 15 seconds after release the aso embolized into the left atrium.In addition, the patient was found to have pericardial effusion.The physician attempted to retrieve the device via snare, however was unsuccessfully.The patient then underwent emergent open heart surgery to have the atrial septal defect repaired, aso removed, pericardial effusion drained, and perforation repaired.It was noted during the explant procedure that at an unknown point, the patient's mitral valve had sustained an injury.The patient was sent to another hospital and put on extracorporeal membrane oxygenation (ecmo); the patient is waiting to undergo surgery to treat the injured mitral valve.

Manufacturer Narrative

An event of embolism of the device, pericardial effusion, perforation, and damage to the mitral valve was reported.Information from the field indicated that the device migrated 15 minutes after it was implanted, and that the device was not thought to be the cause of the pericardial effusion or perforation.The physician though the cause of the device embolism could be insufficient rims or the device being too small.A returned device assessment, to measure the device, 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.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 15099426
• MDR Text Key: 296558942
• Report Number: 2135147-2022-00568
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010168
• UDI-Public: 00811806010168
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SEPTAL OCCLUDER
• Device Catalogue Number: 9-ASD-019
• Device Lot Number: 7310866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2019
• 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
• Treatment: AMPLATZER TREVISIO INTRAVASCULAR DS,9-ATV09F45/80
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female