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

Model Number	9-ASD-028
Medical Device Problem Code	Poor Visibility (4072)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on 26 january 2023, a 28mm amplatzer septal occluder was selected for implant using a 10f amplatzer torqvue delivery sheath.It was noted during procedure that when removing the dilator and guidewire visibility of the delivery sheath was lost on the transesophageal echocardiogram (tee).However, fluoroscopy was used to obtain visibility.It was noted that the left atrial disc of the 28mm amplatzer septal occluder had been deployed, but there was still no visibility noted on the tee.It was noted at this point that the patient had began to develop a pericardial effusion.The decision was made to fully remove the 28mm amplatzer septal occluder and the 10f amplatzer torqvue delivery sheath and aborted the implant procedure.A pericardiocentesis was then performed to drain the patient's pericardial effusion.The patient was then emergently sent to surgery to address a wound sustained to the patient's roof of the left atrium.It was reported that the patient had been removed from extracorporeal circulation and was in stable condition at the time of report.There are no allegations of malfunction against either the occluder or the delivery sheath.
Additional Manufacturer Narrative
An event of pericardial effusion was reported.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2023, a 28mm amplatzer septal occluder was selected for implant using a 10f amplatzer torqvue delivery sheath.It was noted during procedure that when removing the dilator and guidewire visibility of the delivery sheath was lost on the transesophageal echocardiogram (tee).However, fluoroscopy was used to obtain visibility.It was noted that the left atrial disc of the 28mm amplatzer septal occluder had been deployed, but there was still no visibility noted on the tee.It was noted at this point that the patient had began to develop a pericardial effusion.The decision was made to fully remove the 28mm amplatzer septal occluder and the 10f amplatzer torqvue delivery sheath and aborted the implant procedure.A pericardiocentesis was then performed to drain the patient's pericardial effusion.The patient was then emergently sent to surgery to address a wound sustained to the patient's roof of the left atrium.It was reported that the patient had been removed from extracorporeal circulation and was in stable condition at the time of report.There are no allegations of malfunction against either the occluder or the delivery sheath.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: 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: 16315888
• Report Number: 2135147-2023-00423
• Device Sequence Number: 7844191
• Product Code: MLV
• UDI-Device Identifier: 05415067019325
• UDI-Public: 05415067019325
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: 9-ASD-028
• Device Catalogue Number: 9-ASD-028
• Device Lot Number: 7942563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown