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

Model Number	9-PFO-035
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2021, a 35 mm amplatzer patent foramen ovale (pfo) occluder was chosen for procedure of a pfo closure after the pfo measurements were determined via intracardiac echocardiography (ice).The scrub tech and physician prepared the pfo device along with a 9 f amplatzer¿ trevisio¿ intravascular delivery system.After the device cable was pulled through to bring the pfo device from the saline bath into the loader, it was noted that there were bubbles in the loader.The device cable was pushed so that the pfo device came out of the loader and back into the saline bath in attempt to remove all the bubbles from the delivery system.The device was pulled out into the saline bath and back into the loader 3 times in order for no air bubbles to be seen.Once the devices were prepared, the loader was attached to the delivery sheath and the pfo device was advanced into the patient's body.The pfo device was deployed, and the right atrial disc did not lay flat as intended.Attempts were made to push the cable and delivery sheath to try to flatten the disc without success.The right atrial disc was retrieved and redeployed, but the right atrial disc remained expanded and would not lay flat.The decision was made to re-sheath and remove the pfo device from the patient.A 30 mm amplatzer pfo occluder was then successfully implanted using the same delivery system to resolve this event.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
An event of left atrial disc remained deformed upon deployment was reported.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.Please note, per the instructions for use, arten600038249 rev.A, "reposition the device and deploy it again, or remove the device from the patient.The device may be repositioned and recaptured up to 3 times.Do not release the device from the delivery cable if the device does not conform to its original configuration or if device position is unstable or interferes with any adjacent cardiac structure (such as svc, pv, mv, cs, ao).".

• Brand Name: AMPLATZER PFO OCCLUDER
• Common Device Name: 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: 12968845
• Report Number: 2135147-2021-00551
• Device Sequence Number: 4394983
• Product Code: MLV
• UDI-Device Identifier: 00811806011301
• UDI-Public: 00811806011301
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: 9-PFO-035
• Device Catalogue Number: 9-PFO-035
• Device Lot Number: 7538645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown