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

Catalog Number 9-ASD-026

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pericardial Effusion (3271)

Event Date 01/31/2024

Event Type  Injury  

Manufacturer Narrative

An event of pericardial effusion was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Information from the field indicated that pericardial effusion was noted after the procedure and it got worse after the second day.Then, two weeks follow up, pericardial effusion had decreased.Last follow up, the patient had no symptom and images showed minimal pericardial effusion called physiological effusion which is acceptable based on physician's comments.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

It was reported that on 31 jan.2024, a 26mm amplatzer septal occluder was sceleted for an implant.The device was deployed and released successfully according to the ifu's.Follow up transesophageal echocardiogram (tee) was performed the day after the procedure and pericardial effusion was noted on (b)(6) 2024.Follow up tte on the second day showed that the pericardial effusion got worse.Follow up tte two weeks after showed that the pericardial effusion has decreased.Last follow up tte was performed on (b)(6) 2024.The patient had no symptom and images showed minimal pericardial effusion called physiological effusion which is acceptable based on physician's comments.The patient is stable.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18952378
• MDR Text Key: 338302031
• Report Number: 2135147-2024-01293
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010205
• UDI-Public: 00811806010205
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9-ASD-026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• 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 Sex: Female