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

Model Number 9-PFO-030

Device Problems Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

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

Event Date 01/17/2022

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 using a amplatzer trevisio intravascular delivery system, on (b)(6) 2021.Device was prepped according ifu.During deployment, the right disc was not expanding correctly, it appeared bulbous in shape.The device was fully retracted 2 times from the delivery system and was redeployed but the same phenomenon occurred.Device was removed from the patient prior to released from the delivery cable.There was interaction with atrial structures during deployment and no angulation or kink noticed in the delivery system.There was also difficulties advancing the occluder in system.The inner diameter of the delivery sheath catheter was 2.69mm.A new 30mm amplatzer pfo occluder and delivery system was used for successful implantation.Patient stable, no additional information was provided.

Manufacturer Narrative

An event of deformity of device was reported.The investigation confirmed the device met visual and functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined.Please note, as per instructions for use, artmt600034287 rev.B, "warnings: do not release the amplatzer¿ pfo occluder from the delivery cable if the device does not conform to its original configuration or if the device position is unstable.Recapture the device and redeploy.If still unsatisfactory, recapture the device and replace with a new device." and "if the device is in contact with the free atrial wall or any cardiac structures, recapture and replace with a smaller device, if available or abandon the procedure.".

• 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: 13361722
• MDR Text Key: 286239451
• Report Number: 2135147-2022-00034
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• 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: 7889537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2021
• 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