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

Catalog Number UNK AMPLATZER SEPTAL OCCLUDER

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Foreign Body In Patient (2687)

Event Date 09/27/2023

Event Type  Injury  

Event Description

The article, "migration of an atrial septal defect occluder in a pregnant patient", was reviewed.The article presented a case study of a 24-year-old woman at 28 weeks¿ gestation with a medical history of mitral valve prolapse and large ostium secundum atrial septal defect (asd).It was reported that on an unknown date, an unknown amplatzer septal occluder was implanted.It was reported 3 years later on an unknown date, a transthoracic echocardiography (tte) noted the device was well seated with residual shunting.It was then reported 5 years post-procedure on an unknown date, the patient presented with dyspnea with exertion.A tte revealed the measured asd was 26.8mm in diameter but absence of the device.A 2-view chest x-ray revealed the device had embolized into the pulmonary artery and likely endothelialized.Surgical removal was planned but it was reported the patient was lost to follow up after successful delivery with no complications.The article concluded delayed asdo migration is an infrequent and previously unreported complication in a pregnant patient.Transthoracic echocardiogram is a safe, rapid, and noninvasive study during pregnancy that allows asdo localization and hemodynamic evaluation that can help guide decision-making.They reported a conservative approach to an embolized asdo discovered within the pulmonary artery in a hemodynamically stable patient who subsequently underwent uncomplicated delivery.[the primary and corresponding author was rosario colombo, md, department of cardiology, jackson memorial hospital, 1611 nw 12th avenue, miami, florida 33136, with corresponding e-mail: rosario.Colombo@jhsmiami.Org].

Manufacturer Narrative

Literature article: migration of an atrial septal defect occluder in a pregnant patient investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Summarized patient outcomes/complications of amplatzer septal occluder were reported in a research article in a subject population with medical history of mitral valve prolapse.Some of the complications reported were residual shunting, hospitalization, dyspnea and device embolization; 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.Literature attachment: article title: migration of an atrial septal defect occluder in a pregnant patientd1 - brand name, d2a - common device name, d2b - procode, d4 - catalog #.

• 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: 18125261
• MDR Text Key: 327998911
• Report Number: 2135147-2023-04997
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• 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
• Date Manufacturer Received: 11/14/2023
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 24 YR
• Patient Sex: Female