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

Model Number	9-ASD-MF-035
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Myocardial Infarction (1969)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
It was reported on (b)(6) 2021, a 6mm amplatzer septal occluder was selected for implant.The physician crossed the anterior defect and attempted to deliver the amplatzer septal occluder however, it didn't occlude the 3 defects and was deemed too small.The device was exchanged for a 35mm amplatzer septal occluder and the device covered all defects and the device was released.After removing the delivery sheath, compression on the right femoral vein were applied.No major bleeding was noted and the patient was reported to be stable.Later, the patient presented with st elevation myocardial infraction and a code blue was called.Chest decompressions were attempted and the patient underwent cardiac defibrillation.A transthoracic echocardiography and rapid angiography was performed and showed no cardiac tamponade, aortic preformation or right coronary infracts.It is thought that the patient possibly had right ventricle (rv) failure and a an impella rp heart pump was implanted.Once the patient was stable, she was transferred to stanford medical center where she may become a candidate for heart transplant.It is unknown what caused the myocardia infraction, however it is thought that the patient possibly had some type of undiagnosed rv failure.The medical team is very confused as why this happened since the patient was physically active with no presentation or diagnosis of pulmonary hypertension or atrial/ventricular fibrillation.
Event or Problem Description
It was reported on (b)(6) 2021, a 6mm amplatzer septal occluder was selected for implant.The physician crossed the anterior defect and attempted to deliver the amplatzer septal occluder however, it didn't occlude the 3 defects and was deemed too small.The device was exchanged for a 35mm amplatzer cribriform occluder and the device covered all defects and the device was released.After removing the delivery sheath, compression on the right femoral vein were applied.No major bleeding was noted and the patient was reported to be stable.Later, the patient presented with st elevation myocardial infraction and a code blue was called.Chest decompressions were attempted and the patient underwent cardiac defibrillation.A transthoracic echocardiography and rapid angiography was performed and showed no cardiac tamponade, aortic preformation or right coronary infracts.It is thought that that the patient possibly had right ventricle (rv) failure and a an impella rp heart pump was implanted.Once the patient was stable, she was transferred to stanford medical center where she may become a candidate for heart transplant.It is unknown what caused the myocardia infraction, however it is thought that the patient possibly had some type of of undiagnosed rv failure.The medical team is very confused as why this happened since the patient was physically active with no presentation or diagnosis of pulmonary hypertension or atrial/ventricular fibrillation.
Additional Manufacturer Narrative
An event of "st elevation", myocardial infarction, and possible "right ventricle (rv) failure" was reported.A more comprehensive assessment could not be performed as the device remains implanted 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.

• Brand Name: AMPLATZER CRIBRIFORM OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12511831
• Report Number: 2135147-2021-00374
• Device Sequence Number: 17016109
• Product Code: MLV
• UDI-Device Identifier: 00811806010311
• UDI-Public: 00811806010311
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: 10/31/2024
• Device Model Number: 9-ASD-MF-035
• Device Catalogue Number: 9-ASD-MF-035
• Device Lot Number: 7291544
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 39 YR