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

Catalog Number	9-ASD-012
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Erosion (1750); Low Blood Pressure/ Hypotension (1914); Shock (2072); Cardiac Tamponade (2226); Pericardial Effusion (3271); Syncope/Fainting (4411)
Date of Event	05/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of hypotensive, large pericardial effusion with tamponade and device erosion that lead to open heart surgery for removal of device was reported.It was also reported that a patient presented in cardiogenic shock with a pericardial effusion which was drained.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 specifications.Based on the information received, the exact cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Erosion is a possible outcome of the procedure per the amplatzer septal occluder instructions for use.
Event or Problem Description
It was reported that on (b)(6) 2013, a 12mm amplatzer septal occluder was chosen for atrial septal defect (asd) using a 7f amplatzer torqvue delivery system.During procedure 850mg of cefazolin and 15000 units of heparin was administrated.The device was successfully implanted.On (b)(6) 2024, the patient was found down and blue at home, he regained consciousness but very hypotensive.A large pericardial effusion with tamponade was noted.The patient was in the pediatric intensive care unit on pressors and a pericardiocentesis was performed.The patient well tolerated with the procedure and heart rate came down form 120s to 70s and blood pressure increased from 80s to170s.The pressors were rapidly weaned.On (b)(6) 2014, the patient presented in cardiogenic shock with a pericardial effusion which was drained.The blood work was normal but there was a susception of a asd device erosion.The patient was taken to the operating room, device erosion was confirmed and they decided to remove the device and close the asd surgically.The device was removed via transcatheter snare.After the device removal the rendered tissue quite friable.The left atrium was repaired surgically and asd was closed.The patient remained hemodynamically stable.The patient was reported stable and transferred into the cardiac intensive care unit.The patient was reported stable and discharged.

• 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): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19697674
• Report Number: 2135147-2024-03288
• Device Sequence Number: 3641184
• Product Code: MLV
• UDI-Device Identifier: 00811806010090
• UDI-Public: (01)00811806010090(17)171031(10)1211200619
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/08/2024

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: 10/31/2017
• Device Catalogue Number: 9-ASD-012
• Device Lot Number: 1211200619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2012
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 15 YR
• Patient Sex: Unknown
• Patient Weight: 17 KG