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

Device Problem Biocompatibility (2886)

Patient Problem Endocarditis (1834)

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 article, "mobile vegetations on a poorly endothelialized atrial septal defect closure device", was reviewed.This research article reported a case study on a (b)(6)-year old man with a history of atopic dermatitis, that had undergone percutaneous atrial septal defect closure using an amplatzer septal occluder device.Three years post procedure, the patient was hospitalized for urgent surgical treatment for infective endocarditis.The diagnosis was confirmed by blood cultures identifying (b)(6).Transesophageal echocardiography showed a giant mobile mass suspected to represent vegetations around the device at the left atrial site without residual shunt.Through a median sternotomy, cardiopulmonary bypass was established with ascending aortic and bicaval cannulations.After cardioplegic arrest, the right atrium was opened and giant vegetations were observed not only at the left atrial site, but also at the right atrial site.The device was removed along with the giant vegetations.Radical debridement resulted in large defects at both the left and right atrial walls.The left atrial wall was reconstructed with a bovine pericardial patch.A second pericardial patch was then used to reconstruct the right atrial site defect, including interatrial septum.The removed vegetations had mainly proliferated in a poorly endothelialized area of the atrial septal defect closure device.Postoperative course was uneventful, the patient received intravenous levofloxacin therapy for four weeks.The patient was discharged home in good condition with oral levofloxacin antibiotic therapy.Anticoagulation therapy with warfarin was continued for three months postoperatively.The article concluded that as atopic dermatitis is known as a risk factor for infectious endocarditis, surgical atrial septal closure could offer a good alternative to percutaneous device closure for patients with atopic dermatitis.The primary and correspondence author of this article is hideki kitamura, md, phd, 1-1-14 sunadabashi, higashi-ku, nagoya, aichi 461-0045, japan with the corresponding email: kitamura@heart-center.Or.Jp.

Manufacturer Narrative

As reported in a research article, a 20 year old patient with a history of atopic dermatitis underwent atrial septal defect closure and was implanted with an amplatzer septal occluder.Three years post procedure the patient was diagnosed with infective endocarditis and the device was explanted.Vegetations were noted on both the left and right atrial sites.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received 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
• MDR Report Key: 11396525
• MDR Text Key: 234502518
• Report Number: 2135147-2021-00079
• 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,l
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

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: 02/01/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 20 YR