MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-ASD-026

Device Problem Material Erosion (1214)

Patient Problems Hematoma (1884); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 10/05/2019

Event Type  Injury  

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 Description

The implanting physician reported a case of erosion of an aso device he had implanted in july.The patient presented last weekend with acute onset of chest pain and syncope.She went to the hospital where she had a large pericardial effusion and then transferred to santa clara kaiser.There, they took her to or in the am and found a right atrial rupture as well as a hematoma of the aorta that had not yet extended all the way through.The physician stated she is recovering nicely.The physician said the patient had a deficient anterior posterior rim.A 26 mm aso was successfully implanted.No patient consequences reported.

Manufacturer Narrative

An event of chest pain, syncope, pericardial effusion, right atrial rupture hematoma of the aorta, and erosion of the device was reported.The results of the investigation are inconclusive since the device was not returned for analysis, however seven photos were received from the field, which confirmed the pericardial effusion reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note per the instructions for use, artmt100092311 revision b, " physicians should be aware of the risk of erosion.Erosion may be the result of a complex set of interactions between factors including, but not limited to the underlying anatomic substrate, retro-aortic rim of less than 5mm in any echocardiographic plane, and the dynamic hemodynamic counter motion between the atrium and the aorta.However, there is insufficient data including inadequate echocardiographic information about the cases already reported to determine the etiology of erosion.".

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9273926
• MDR Text Key: 165116659
• Report Number: 2135147-2019-00343
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010205
• UDI-Public: 00811806010205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 9-ASD-026
• Device Catalogue Number: 9-ASD-026
• Device Lot Number: 6722585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2018
• 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; Life Threatening; Other