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

Model Number 9-ASD-019

Device Problems Migration or Expulsion of Device (1395); Positioning Problem (3009); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Arrest (1762)

Event Date 02/08/2022

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event 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.

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 286114472
• Report Number: 3005334138-2022-00102
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010168
• UDI-Public: 00811806010168
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention