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

Model Number 9-PFO-035

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

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

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported a 35 mm amplatzer pfo occluder was chosen for procedure.During the device preparation, the occluder presented with a deformation when being pushed out of the loader.The user manually restored the device into its original shape and a second attempt at deployment was made.The device was delivered into the atrium however, the right side of the disc was deployed with another deformation.Although the user repeated attempts (resheathed 5x inside the patient) were made to achieve the normal shape of the device during deployment, the deformation persisted.The user removed the device and it was exchanged for a new, 35mm amplatzer pfo occluder.The device was placed successfully.No adverse or health consequences to the patient.The event did not prolong the procedure.

Event Description

Subsequent to the initially filed information, the following information was received (b)(6), 2021 which confirmed the device presented with deformation during device preparation.The device did not have contact with the patient.

Manufacturer Narrative

The reported event of "the occluder presented with a deformation" could not be confirmed.A more comprehensive 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.Based on the information received, the cause of the reported incident could not be conclusively determined.H10: based on the additional information received, this is no longer considered a reportable event as the deformation of the device occurred during device preparation and had no contact with the patient.

• 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: 12844373
• MDR Text Key: 281033253
• Report Number: 2135147-2021-00483
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011301
• UDI-Public: 00811806011301
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P120021
• 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: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-PFO-035
• Device Catalogue Number: 9-PFO-035
• Device Lot Number: 7172411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2019
• 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