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

Catalog Number UNK AMPLATZER SEPTAL OCCLUDER

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Arrhythmia (1721); Erosion (1750); Stroke/CVA (1770); Endocarditis (1834); Headache (1880)

Event Type  Injury  

Event Description

The article, "comparison of anatomical features and postoperative clinical results of asd between two types of asd closure devices", was reviewed.This research article is a retrospective single center experience to analyze the postoperative clinical results between both devices and the anatomical features of each atrial septal defect in the hospital.Devices involved included amplatzer septal occluder (aso) and figulla flex ii septal occluder (fso).The article concluded that asos were placed in posterior rim defect cases and fsos in aortic-superior rim defect, septal m malalignment, and extensive rim defect cases, but there were no differences in patient characteristics or treatment efficacy and safety outcomes between the two devices.[the author of this article is kotaro miura, md, department of cardiology, keio university hospital, 35 shinanomachi, shinjuku-ku, tokyo 160-8582].

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

As reported in a research article, 214 patients underwent percutaneous asd closures between october 2014 and february 2020; the devices associated with this study were amplatzer septal occluder (aso) and figulla flex ii septal occluder (fso).There were no differences in the clinical performance of death, erosion, dropout, stroke, infective endocarditis, new-onset supraventricular tachyarrhythmia, new-onset migraine, and residual shunting between the two groups.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review, and no device or additional patient information was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.H6 medical device problem code 4001 removed and 2993 was added.

• 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: 14464885
• MDR Text Key: 293650048
• Report Number: 2135147-2022-00306
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

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?: 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
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/21/2022
• Supplement Dates Manufacturer Received: 05/23/2022
• Supplement Dates FDA Received: 06/15/2022
• 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 Age: 53 YR