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

Device Problems Biocompatibility (2886); Human-Device Interface Problem (2949)

Patient Problems Stroke/CVA (1770); Muscle Weakness (1967); Paralysis (1997); Speech Disorder (4415); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a patient was implanted with an amplatzer septal occluder; an event of device-adherent thrombus, mal-apposition of the left atrial disc, incomplete endothelization, and device explant was reported.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.

Event Description

The article, "novel use of the sentinel cerebral protection device during thrombosed septal occluder explant and atriclip appendage closure" was reviewed.This research article presents a case study on a (b)(6)-year-old male who presented with transient left hemi-body weakness, left facial droop, and dysarthria.The patient had experienced multiple strokes and transient ischemic attacks (tias) over a 10-year period resulting in residual right hemiplegia.Shortly after the patient's initial stroke, an ostium secundum atrial septal defect (asd) was diagnosed, followed by percutaneous closure using an amplatzer septal occluder device.Transthoracic echocardiogram with agitated saline injection showed an amplatzer septal occluder device with residual left to right interatrial shunt.Transesophageal echocardiography (tee), which had not been performed since the time of asd-occluder implant, revealed device-associated thrombus on the left atrial side and residual shunt.Over a period of 8 months, the patient was trialed on multiple anticoagulants, including warfarin and several direct oral anticoagulants, with excellent adherence, but without thrombus resolution.A decision was made to surgical explant the asd device.Given concern for embolization during explant, an sentinel¿ cerebral protection device (scpd) was placed.Excision of the amplatzer septal occluder device demonstrated mal-apposition of the left atrial disc, incomplete endothelialization, and numerous microthrombi.A bovine pericardial patch repair was used to correct the ostium secundum defect and a 45 mm atriclip appendage closure (aac) (atricure©) was deployed.The sentinel filter baskets were sequentially recaptured in reverse order and removed from the body.A notable debris burden was demonstrated by extra-corporeal basket filtration.The patient was successfully weaned of cardiopulmonary bypass (cpb) without incident.The primary author of the article is cristina nunez-pellot, md, department of medicine, morsani college of medicine, university of south florida.The correspondence author of the article is jeet j.Mehta, md, department of medicine, university of south florida, 2 tampa general cir, 5th floor cardiology, tampa, fl 33606, usa, with the corresponding email: mehtaj@usf.Edu.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12206716
• MDR Text Key: 262883491
• Report Number: 2135147-2021-00294
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2021
• 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