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

Model Number 9-ASD-026

Device Problems Patient-Device Incompatibility (2682); Biocompatibility (2886)

Patient Problems Chest Pain (1776); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 12/26/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

A 26mm amplatzer septal occluder was chosen for procedure on (b)(6) 2021.In (b)(6) 2021 the patient underwent echocardiogram imaging of the implant and it was determined everything "looked good." during another follow-up in the clinic on (b)(6) 2021, the patient presented with "acute chest pain, mal-perfusion and shock." a large pericardial effusion with tamponade physiology was discovered.The patient underwent an emergent pericardial drain placement in the emergency department (ed), 500ml was drained.He was stabilized and transferred to hershey for further management.The amplatzer septal occluder was observed within the atrial septum with evidence of perforation at the roof of the right(or possibly left) atrium adjacent to the aortic root with abundant clot within the mediastinum, but no active bleeding was appreciated.The perforation was surgically repaired and the patient was hemodynamically stable throughout the procedure, no complications were reported.In the physicians opinion the tissue erosion/pericardial effusion may have been caused by the presence of a "significant pectus excavatum." no additional information has been provided.

Manufacturer Narrative

An event of acute chest pain, ¿mal-perfusion and shock¿, pericardial effusion, and tamponade was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.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): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13258098
• MDR Text Key: 284720360
• Report Number: 2135147-2021-00598
• Device Sequence Number: 1
• Product Code: MLV
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-026
• Device Catalogue Number: 9-ASD-026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 13 YR
• Patient Sex: Male