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

Model Number 9-ASD-024

Device Problem Human-Device Interface Problem (2949)

Patient Problem Transient Ischemic Attack (2109)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a patient was implanted with a 24mm amplatzer atrial septal occluder (aso) device; an event of transient ischemic attack, "excess separation and splay noted between the right and left atrial discs", and residual shunt 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

Related manufacturing reference number: (b)(4).The article, "persistent residual shunts after atrial septal defect closure with the amplatzer septal occluder", was reviewed.This research article reported a case study of a (b)(6) male patient who had a pulmonary valvotomy under inflow stasis at 1 year of age.At the age (b)(6) he suffered a stroke and was found to have a secundum atrial septal defect with a right to left shunt.A 24mm amplatzer atrial septal occluder (aso) device was implanted under intracardiac echocardiographic (ice) guidance at an outside hospital.The defect reportedly measured 19 mm on 2d imaging with adequate rims, it was not balloon sized.One year after device placement the patient had a transient ischemic attack, and there was still a detectable right to left atrial shunt with valsalva.Cardiac catheterization showed no shunt by oximetry although left to right flow was seen on transesophageal echocardiography (tee).Tee demonstrated flow through the discs likely from an oversized device based on the excess separation and splay noted between the right and left atrial discs on multiple views.The central waist measured 21.7 mm suggesting incomplete device expansion a catheter passed easily from the right atrium at the anterior/inferior margin of the device into the left atrium superiorly.Angiography demonstrated a ¿tunnel¿ from the residual communication anteriorly between the discs with anterior/inferior and posterior/superior right atrial communications, and a superior left atrial communication.An attempt to fill the tunnel with coils left a residual right to left shunt; 7 non-abbott coils were implanted.The patient was maintained on aspirin without further neurological events.[the primary and corresponding author is gurumurthy hiremath, md, director, (b)(6), university of (b)(6).

Manufacturer Narrative

As reported in a research article, a patient was implanted with a 24mm amplatzer atrial septal occluder (aso) device; an event of transient ischemic attack, "excess separation and splay noted between the right and left atrial discs", and residual shunt 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

Related manufacturing reference number: 2135147-2021-00603.The article, "persistent residual shunts after atrial septal defect closure with the amplatzer septal occluder", was reviewed.This research article reported a case study of a (b)(6) male patient who had a pulmonary valvotomy under inflow stasis at 1 year of age.At the age (b)(6) he suffered a stroke and was found to have a secundum atrial septal defect with a right to left shunt.A 24mm amplatzer atrial septal occluder (aso) device was implanted under intracardiac echocardiographic (ice) guidance at an outside hospital.The defect reportedly measured 19 mm on 2d imaging with adequate rims, it was not balloon sized.One year after device placement the patient had a transient ischemic attack, and there was still a detectable right to left atrial shunt with valsalva.Cardiac catheterization showed no shunt by oximetry although left to right flow was seen on transesophageal echocardiography (tee).Tee demonstrated flow through the discs likely from an oversized device based on the excess separation and splay noted between the right and left atrial discs on multiple views.The central waist measured 21.7 mm suggesting incomplete device expansion a catheter passed easily from the right atrium at the anterior/inferior margin of the device into the left atrium superiorly.Angiography demonstrated a ¿tunnel¿ from the residual communication anteriorly between the discs with anterior/inferior and posterior/superior right atrial communications, and a superior left atrial communication.An attempt to fill the tunnel with coils left a residual right to left shunt; 7 non-abbott coils were implanted.The patient was maintained on aspirin without further neurological events.[the primary and corresponding author is gurumurthy hiremath, md, director, pediatric cardiac catheterization, university of minnesota masonic childrens hospital, 2450 riverside avenue, minneapolis mn 55454, with email address: hiremath@umn.Ed].

• 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: 13153028
• MDR Text Key: 285396959
• Report Number: 2135147-2021-00601
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ASD-024
• Device Catalogue Number: 9-ASD-024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2021
• 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
• Patient Age: 38 YR
• Patient Sex: Male