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

Catalog Number	9-ASD-034
Medical Device Problem Codes	Off-Label Use (1494); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	08/21/2023
Type of Reportable Event	Death
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 (b)(6) 2023, a 24mm amplatzer post-infarct muscular vsd occluder was chosen for implant.The patient had previously presented to the hospital with a myocardial infarction on (b)(6) 2023, and the device was chosen to emergently close a post-infarct ventricular septal defect (vsd).The dimensions of the defect were approximately 20mm x 28mm, and the sizing of the device was determined using transesophageal echocardiography.Prior to procedure on (b)(6) 2023, the patient presented with a large ventricular septal rupture and was in profound cardiogenic shock requiring impella device support, hypotension, acute pulmonary edema, and renal failure.The vsd occluder was initially placed but was too small for the defect, so it was removed prior to release from delivery cable.The device was replaced with a 34mm amplatzer septal occluder and then successfully implanted to close the vsd with a small residual shunt left.The physician was aware that this was off-label use to implant an aso device into a vsd, but the decision was made to use an aso device since there was not a larger vsd device available.The patient was returned to the cardiac intensive care unit (icu) for recovery.The patient continued to be in cardiogenic shock and hypotensive which required mechanical support.Later that evening, the patient expired.The implanter classified this death as likely related to the patient's comorbidities, and no allegation of malfunction was made against the device.
Additional Manufacturer Narrative
An event of cardiogenic shock and death was reported.Information from the field indicated that the patient had previously presented to the hospital with a myocardial infarction and underwent attempted closure of a post-infarct muscular vsd, but the device chosen was too small for the size of the defect and was replaced by the off label use of an amplatzer septal occluder.A returned device assessment could not be performed as the device remains implanted and 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 cause of death is due to cardiogenic shock due to an underlying myocardial infarction.Per the instructions for use,arten600196097 - b, stated "indication and usage:the amplatzer¿ septal occluder is a percutaneous, transcatheter atrial septal defect closure device intended for the occlusion of atrial septal defects (asds) in secundum position or patients who have undergone a fenestrated fontan procedure and who now require closure of the fenestration".

• 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: 17755719
• Report Number: 2135147-2023-03992
• Device Sequence Number: 7210457
• Product Code: MLV
• UDI-Device Identifier: 00811806010243
• UDI-Public: 00811806010243
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

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: 03/31/2024
• Device Catalogue Number: 9-ASD-034
• Device Lot Number: 6953059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2019
• 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: Death
• Patient Age: 67 YR
• Patient Sex: Male