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

Catalog Number 9-ASD-040

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 12/06/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2023, a 40mm amplatzer septal occluder was selected for implant using a 12f amplatzer torqvue delivery system.The patient's atrial septal defect was measured on transesophageal echocardiogram (tee) as between 30-35mm.The patient was placed under general anesthesia and the procedure was carried out under tee guidance.During procedure, there was some difficulty experienced implanting the device due to the width of the discs.It was noted during procedure that the occluder had embolized shortly after being released, despite various stability tests.While the tee probe was still in place, it was noted that occluder migrated from left to right atrium.Passed to the level of the right ventricle, and stopped pulmonary artery without obstruction of the artery.It was also noted that the patient became hypotensive.The decision was made to attempt explant of the occluder using an unknown 3-loop clamp and lasso system, but was unsuccessful.The patient underwent surgery, had the 40mm amplatzer septal occluder explanted, was treated for injury of the pulmonary valve caused by snare attempt, and had the atrial septal defected closed/treated with an unknown patch.The patient status was reported as extubated and stable.

Manufacturer Narrative

An event of the device embolizing after placement was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated the device was too small for the defect, and that the defect was surgically closed with a patch.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 18412630
• MDR Text Key: 331578124
• Report Number: 2135147-2023-05772
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ASD-040
• Device Lot Number: 7329675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2020
• 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; Hospitalization