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

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

Patient Problems Adhesion(s) (1695); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The following case study was reported on social media: a (b)(6) year old male patient who had received an amplatzer septal occluder device years ago presented with acute pericardial effusion.Upon the operation, 1000ml of hemorrhagic pericardial effusion were released and recent fibrinous adhesions between the right atrial wall and the coronary aspect of the aortic wall were identified.After blunt dissection of the adhesions, an imminent perforation of the cranial, uncovered rim of the nitinol frame of the amplatzer device through the atrial wall was identified.The device was carefully explanted by sharp dissection and the atrial septal defect(asd) was closed with a goretex patch.The further course of the patient was uneventful.

Manufacturer Narrative

An event of pericardial effusion, fibrinous adhesions between the right atrial wall and coronary aspect of the aortic wall, imminent perforation of the cranial where the amplatzer was noted and explanted was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device was manufactured according to specifications as supported by the receiving inspection results.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
• MDR Report Key: 11520473
• MDR Text Key: 249447059
• Report Number: 2135147-2021-00098
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR