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

Model Number 9-PFO-030

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported that a 30mm amplatzer patent foramen ovale (pfo) occluder was selected for an implant on (b)(6) 2022.After defect analysis with intracardiac ultrasound, device was chosen, due to a thick septum secundum.Using the dedicated delivery system, the device was placed in the left atrium and the left disc was open.However, the left disc failed to acquire its normal configuration.Instead, it conformed into an oval structure that appeared bulbous in shape.Nevertheless, the right disc was unsheathed in an attempt to make the device conform properly, but unfortunately the left disc remained in its wrong configuration.The device was retrieved and tested on the table.Again, when unsheathing it failed to assume its correct configuration, assuming a voluminous and oval shape.There was no interaction with atrial structures during deployment and no angulation or kink noticed in the delivery system.Subsequently, a 25 mm amplatzer pfo device was placed and deployed uneventfully, with a satisfactory result.The patient was discharge the morning after, in good condition.No additional information was provided.

Manufacturer Narrative

An event of bulbous deformation was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis; however, one video was received for analysis.Based solely on the aforementioned video, the occluder appeared to deploy in a bulbous conformation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER PFO 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: 13399078
• MDR Text Key: 286571451
• Report Number: 2135147-2022-00035
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-PFO-030
• Device Lot Number: 7874532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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