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

Catalog Number UNK AMPLATZER SEPTAL OCCLUDER

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2006

Event Type  malfunction  

Event Description

The article, "a comparison of intracardiac echocardiography and transesophageal echocardiography for guiding device closure of ostium secundum atrial septal defect: a 15-year experience", was reviewed.The article presented a retrospective, single center study to evaluate the fluoroscopy time (ft), procedure time (pt) safety and efficacy when using intracardiac echocardiography (ice) in comparison to transesophageal echocardiography (tee) guidance for transcatheter closure of ostium secundum atrial septal defect (os-asd).Devices included amplatzer septal occluder, amplatzer ¿cribriform¿ septal occluder (st jude medical), figulla asd (fso, occlutech gmbh), ceraflex asd occluder (lifetech scientific), atriasept asd occluder (cardia), solysafe asd occluder, and swissimplant.The article concluded this study on a consistent cohort of patients with os-asd undergoing percutaneous closure suggests that use of ice is safe and efficacious.Compared to tee, ice demonstrated significantly shorter ft and pt, decreasing the entire duration of the procedure and x-ray exposure.No relevant differences were observed in terms of success rate and complications.[the primary and corresponding author was andrea igoren guaricci, fesc, interdisciplinary department ofmedicine, university of bari aldo moro, piazza giulio cesare 11, bari, italy, with corresponding email: (b)(6)].

Manufacturer Narrative

B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided the additional patient effects reported in the article are captured under a separate medwatch report summarized patient outcomes/complications of a comparison of intracardiac echocardiography and transesophageal echocardiography for guiding device closure of ostium secundum atrial septal defect were reported in a research article in a subject population with multiple co-morbidities including paradoxical embolism, multi-fenestrated septum, atrial septal aneurysm, ostium secundum atrial septal defect.Some of the complications reported were device migration and percutaneously snare these complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.

• 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: 18445216
• MDR Text Key: 332617393
• Report Number: 2135147-2024-00056
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• 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: 12/11/2023
• 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