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

Model Number 9-ASD-030

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Air Embolism (1697); Arrhythmia (1721); Bradycardia (1751); Stroke/CVA (1770); Embolism/Embolus (4438)

Event Date 03/25/2022

Event Type  Injury  

Event Description

It was reported that a 28mm amplatzer septal occluder was selected for an implanted on (b)(6) 2022 for an atrial septal defect closure procedure.Using a 24mm unknown sizing balloon, the defect was sized at 27mm.The 28mm occluder was prepped and delivered to the defect.Intracardiac echocardiography (ice) showed some insufficient apposition to the aortic root (ao) rim, and when the stability test was performed, the device prolapsed thru the defect.The device was recaptured and removed from the patient prior to release from the delivery cable.A 30mm amplatzer septal occluder was prepped and delivered to the defect.Ice imaging showed better apposition to the rims, with some color doppler flow noted thru the device, but not around either disc.It was noted that three separate stability checks were performed with each one showing the device to be stable on the septum.The device was released from the delivery cable and subsequent ice imaging showed the device to be seated well on the septum.The patient remained stable at the point.Two preclose devices were prepped for deployment, as the first preclose was being deployed, the patient began to experience some ectopy, when the patient was placed under fluoroscopy, the device was noted to have embolized complete into the patient right pulmonary artery (pa).The right pa was not completely occluded.The decision was made to prepare for device retrieval using a large 12 fr sheath and a gooseneck snare.The patient continued to remain stable.After numerous unsuccessful attempts to snare the device, an ensnare was then introduced to try and snare the device after removing the gooseneck snare.Another sheath was placed in the left femoral artery and a pig tail catheter was introduced into the pa to try and steer the device while attempting to snare it.These attempts were also unsuccessful and towards the end of this attempt, a series of air bubbles were noted on the fluoroscopy moving thru the pa.The patient became unstable with stroke/seizure like symptoms, unable to focus or respond along with decreased heart rate and blood pressure.High flow oxygen was given along with atropine and fluids.The patient rapidly regained movement and eye focus and remained somewhat stable.The stroke team was present at this time and the decision was made to take the patient to computerized tomography (ct).The patient remained in the unit with high flow oxygen and heparin.Once stable, the patient was taken to emergency surgery to remove the 30mm amplatzer septal occluder and patch the defect.The event did contribute to a clinically significant delay in procedure.At the time of report, the patient was noted to have been recovering.

Manufacturer Narrative

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

Event Description

N/a.

Manufacturer Narrative

An event of device embolization, ectopy, and stroke/seizure like symptoms was reported.A returned device assessment could not be performed as the device remains in the patient and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 14191078
• MDR Text Key: 289958657
• Report Number: 2135147-2022-00197
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067019332
• UDI-Public: 05415067019332
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ASD-030
• Device Catalogue Number: 9-ASD-030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• 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): Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female