MAUDE Adverse Event Report: ST. JUDE MEDICAL (SH-PLYMOUTH) AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	9-ASD-019
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Positioning Problem (3009); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	02/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
It was reported that a 19mm amplatzer septal occluder was selected for an implant on (b)(6) 2022.Device was sized using an 18mm unknown manufacturer balloon sizing.During the deployment of the device, the device shifted position within the intended site and obstructed the flow of the aorta; the patient had severe septal aneurysms and the atrioventricular (av) rim was pressed by the device.The patient went into cardiac arrest and was sent to surgery.The device came out of the patient without being detached from the delivery cable.There was clinically significant delay in the procedure as the result of severe septal aneurysms and atrioventricular (av) rim was pressed by the device.Patient stable, the patient did not have a history of aneurysms, no additional information was provided.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
It was reported that a 19mm amplatzer septal occluder was selected for an implant on (b)(6) 2022.Device was sized using an 18mm unknown manufacturer balloon sizing.During the deployment of the device, the device shifted position within the intended site and obstructed the flow of the aorta; the patient had severe septal aneurysms and the atrioventricular (av) rim was pressed by the device.The patient went into cardiac arrest and was sent to surgery.The device came out of the patient without being detached from the delivery cable.There was clinically significant delay in the procedure as the result of severe septal aneurysms and atrioventricular (av) rim was pressed by the device.Patient stable, the patient did not have a history of aneurysms, no additional information was provided.
Additional Manufacturer Narrative
An event of "septal aneurysms", "cardiac arrest" and "device came out of the patient without being detached from the delivery cable" was reported.A more comprehensive 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 specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ST. JUDE MEDICAL (SH-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL (SH-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13592156
• Report Number: 3005334138-2022-00102
• Device Sequence Number: 3769818
• Product Code: MLV
• UDI-Device Identifier: 00811806010168
• UDI-Public: 00811806010168
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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 Expiration Date: 11/30/2025
• Device Model Number: 9-ASD-019
• Device Catalogue Number: 9-ASD-019
• Device Lot Number: 7768147
• Was Device Available for Evaluation?: No
• 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: 02/08/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown