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

Model Number	9-ASD-022
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Erosion (1750); Cardiac Arrest (1762); Perforation (2001)
Date of Event	12/11/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a 22mm unknown amplatzer occluder was chosen for implant using an unknown delivery system for an atrial septal defect (asd) closure.The device was successfully deployed, and the patient was transferred from the cardiac catheterization laboratory to the hospital floor in stable condition.On (b)(6) 2025, a transthoracic echocardiogram (tte) was performed and reported as unremarkable.The patient was being prepared for discharge later that day and reportedly consumed a large meal prior to the planned discharge.Subsequently, the patient experienced cardiac arrest accompanied by significant vomiting.Airway management was reported to be challenging, with unsuccessful intubation attempts for approximately 25 minutes, after which a tracheostomy was performed to secure the airway.The patient was then taken to the operating room (or).During surgery, the implanted device was extracted, and intraoperative findings reportedly included erosion with a 2 mm perforation in the left atrial wall and a pinpoint perforation in the aorta.The anatomy was repaired, and the patient was transferred to the post-anesthesia care unit (pacu) in stable condition.The patient was subsequently admitted to the intensive care unit (icu) and remained hemodynamically stable.Over the following days, magnetic resonance imaging (mri) of the brain was performed and reportedly indicated anoxic brain injury, attributed to the prolonged airway management period.Initially, it was reported that the family intended to withdraw care on 22 december 2025; however, as of (b)(6)2025, the patient remained in the icu with some cranial reflexes, and the family had decided not to withdraw care at that time.
Additional Manufacturer Narrative
The device is not returning for evaluation.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) 2025, a 22mm amplatzer septal occluder was chosen for implant using an 10f amplatzer trevisio delivery system for an atrial septal defect (asd) closure.The patient was reported to be stable prior to implant procedure.The device was successfully deployed, and the patient was transferred from the cardiac catheterization laboratory to the hospital floor in stable condition.On (b)(6) 2025, a transthoracic echocardiogram (tte) was performed and reported as unremarkable.The patient was being prepared for discharge later that day and reportedly consumed a large meal prior to the planned discharge.Subsequently, the patient experienced cardiac arrest accompanied by significant vomiting.Airway management was reported to be challenging, with unsuccessful intubation attempts for approximately 25 minutes, after which a tracheostomy was performed to secure the airway.The patient was then taken to the operating room (or).During surgery, the implanted device was extracted, and intraoperative findings reportedly included erosion with a 2 mm perforation in the left atrial wall and a pinpoint perforation in the aorta.The anatomy was repaired, and the patient was transferred to the post-anesthesia care unit (pacu) in stable condition.The patient was subsequently admitted to the intensive care unit (icu) and remained hemodynamically stable.Over the following days, magnetic resonance imaging (mri) of the brain was performed and reportedly indicated anoxic brain injury, attributed to the prolonged airway management period.Initially, it was reported that the family intended to withdraw care on (b)(6) 2025; however, as of (b)(6) 2025, the patient remained in the icu with some cranial reflexes, and the family had decided not to withdraw care at that time.The implanter classified the event as being related to the device.On (b)(6) 2026, it was reported that on (b)(6) 2025, the life supporting measures were removed and the patient passed away from severe anoxic brain injury.The physician classifies this death being related to the implanted device.
Additional Manufacturer Narrative
An event of a patient device incompatibility, erosion, perforation, cardiac arrest, and death was reported.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 defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the information received from the field and medical review, the cause for the reported patient device incompatibility, erosion, and perforation could not be determined.The reported cardiac arrest and death were likely cascading effects from the event; however, this cannot be determined.Unexpected medical interventions were a result of case specific circumstances, as an unsuccessful intubation and tracheostomy were performed.Surgical interventions were a result of case specific circumstances, as the device was extracted and the anatomy was repaired.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) 2025, a 22mm amplatzer septal occluder was chosen for implant using an 10f amplatzer trevisio delivery system for an atrial septal defect (asd) closure.The patient was reported to be stable prior to implant procedure.The device was successfully deployed, and the patient was transferred from the cardiac catheterization laboratory to the hospital floor in stable condition.On (b)(6) 2025, a transthoracic echocardiogram (tte) was performed and reported as unremarkable.The patient was being prepared for discharge later that day and reportedly consumed a large meal prior to the planned discharge.Subsequently, the patient experienced cardiac arrest accompanied by significant vomiting.Airway management was reported to be challenging, with unsuccessful intubation attempts for approximately 25 minutes, after which a tracheostomy was performed to secure the airway.The patient was then taken to the operating room (or).During surgery, the implanted device was extracted, and intraoperative findings reportedly included erosion with a 2 mm perforation in the left atrial wall and a pinpoint perforation in the aorta.The anatomy was repaired, and the patient was transferred to the post-anesthesia care unit (pacu) in stable condition.The patient was subsequently admitted to the intensive care unit (icu) and remained hemodynamically stable.Over the following days, magnetic resonance imaging (mri) of the brain was performed and reportedly indicated anoxic brain injury, attributed to the prolonged airway management period.Initially, it was reported that the family intended to withdraw care on (b)(6) 2025; however, as of (b)(6) 2025, the patient remained in the icu with some cranial reflexes, and the family had decided not to withdraw care at that time.The implanter classified the event as being related to the device.On 11 february 2026, it was reported that on (b)(6) 2025, the life supporting measures were removed and the patient passed away from severe anoxic brain injury.The physician classifies this death being related to the implanted device.
Additional Manufacturer Narrative
An event of a patient device incompatibility, erosion, perforation, cardiac arrest, and death was reported.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the information received from the field and medical review, the cause for the reported patient device incompatibility, erosion, and perforation could not be determined.The reported cardiac arrest and death were likely procedure related and cascading effects from the event; however this cannot be determined.Unexpected medical interventions were a result of case specific circumstances, as an unsuccessful intubation and tracheostomy were performed.Surgical interventions were a result of case specific circumstances, as the device was extracted and the anatomy was repaired.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.Codes removed: type of investigation: 4114 investigation findings: 3221 investigation conclusions: 4315.
Event or Problem Description
It was reported that on (b)(6) 2025, a 22mm amplatzer septal occluder was chosen for implant using an 10f amplatzer trevisio delivery system for an atrial septal defect (asd) closure.The patient was reported to be stable prior to implant procedure.The device was successfully deployed, and the patient was transferred from the cardiac catheterization laboratory to the hospital floor in stable condition.On (b)(6) 2025, a transthoracic echocardiogram (tte) was performed and reported as unremarkable.The patient was being prepared for discharge later that day and reportedly consumed a large meal prior to the planned discharge.Subsequently, the patient experienced cardiac arrest accompanied by significant vomiting.Airway management was reported to be challenging, with unsuccessful intubation attempts for approximately 25 minutes, after which a tracheostomy was performed to secure the airway.The patient was then taken to the operating room (or).During surgery, the implanted device was extracted, and intraoperative findings reportedly included erosion with a 2 mm perforation in the left atrial wall and a pinpoint perforation in the aorta.The anatomy was repaired, and the patient was transferred to the post-anesthesia care unit (pacu) in stable condition.The patient was subsequently admitted to the intensive care unit (icu) and remained hemodynamically stable.Over the following days, magnetic resonance imaging (mri) of the brain was performed and reportedly indicated anoxic brain injury, attributed to the prolonged airway management period.Initially, it was reported that the family intended to withdraw care on (b)(6) 2025; however, as of (b)(6) 2025, the patient remained in the icu with some cranial reflexes, and the family had decided not to withdraw care at that time.The implanter classified the event as being related to the device.On 11 february 2026, it was reported that on (b)(6) 2025, the life supporting measures were removed and the patient passed away from severe anoxic brain injury.The physician classifies this death being related to the implanted device.

• 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 MN 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23967643
• Report Number: 2135147-2026-00080
• Device Sequence Number: 15788511
• Product Code: MLV
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 06/25/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-022
• Device Catalogue Number: 9-ASD-022
• Device Lot Number: 10317650
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 02/11/2026; 03/26/2026; 06/05/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/06/2026; 04/03/2026; 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• 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; Required Intervention; Disability
• Patient Sex: Unknown