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

Catalog Number UNK AMPLATZER SEPTAL OCCLUDER

Device Problem Off-Label Use (1494)

Patient Problems Atrial Fibrillation (1729); Renal Failure (2041)

Event Date 09/21/2023

Event Type  Injury  

Manufacturer Narrative

Literature article: hybrid closure of postinfarction apical ventricular septal defect using septal occluder device and right ventricular free wall: the apical bassinet concept investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The article, ¿hybrid closure of postinfarction apical ventricular septal defect using septal occluder device and right ventricular free wall: the apical bassinet concept¿, was reviewed.The article presented a retrospective, single center study on clinical outcomes after a novel hybrid transcatheter/surgical repair in patients with apical ventricular septal defect (vsd).Devices included in this study were amplatzer septal occluder, amplatzer cribriform multi-fenestrated septal occluder, 2-0 force fiber suture, teflon ptfe felt (bard), titanium sternal fixation plate (depuy synthes), and physio ring (edwards lifesciences).The article concluded that early intervention with a hybrid transcatheter/surgical repair may be a viable alternative to traditional surgery for postinfarction apical vsd.[the primary and corresponding author was vasilis babaliaros, division of cardiology,(b)(6) center, (b)(6) hospital midtown, (b)(6), with corresponding email (b)(6)] the time frame of the study was from 2010 to 2021.A total of 7 patients received the apical bridge across septum using suture in a non-endoluminal trajectory (bassinet) procedure with an abbott device, and 9 underwent surgical repair and did not receive a device.The average age was 67 years, and the average gender was female.Comorbidities included hypertension, diabetes, prior percutaneous coronary intervention, prior coronary artery bypass graft, smoking, dialysis, atrial fibrillation, myocardial infarction, cardiogenic shock, mechanical support (extracorporeal membrane oxygenation [ecmo], intraaortic balloon pump [iabp], and impella).

Manufacturer Narrative

An event of off-label use of an amplatzer septal occluder to close a ventricular septal defect was reported in a research article.Outcomes reported included death, surgical intervention, acute kidney injury and atrial fibrillation.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.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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): 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: 17940383
• MDR Text Key: 325743792
• Report Number: 2135147-2023-04516
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER SEPTAL OCCLUDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• 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; Death