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

Catalog Number	9-PFO-025
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6)2023, a a 25mm amplatzer pfo occluder was chosen for a procedure using a 10f amplatzer trevisio intravascular delivery system.During procedure, it was noted that the device had a cobra deformation.The deformed device was never released from the delivery cable while inside the patient.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The physician decided to change the device because it was unsafe to used.A new 25mm amplatzer pfo occluder was chosen and completed the procedure with no adverse effects.The patient was reported stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of device deformity was reported.A returned device assessment could not be performed as the device was not returned for analysis.One image from field appeared to show partially deployed occluder device showing cobra conformation on the distal disc.The device appeared to be covered in blood.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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Information from field indicated that the the patient was slated for atrial septal defect (asd) closure.Please note that per the instructions for use, "the amplatzer¿ pfo occluder is a percutaneous, transcatheter occlusion device intended to close all types of pfos (i.E.Classical as well as those with aneurysm of the septum) in patients with a history of stroke or transient ischemic attacks (tias) diagnosed by echocardiography with right-to-left shunting during the valsalva maneuver.
Event or Problem Description
It was reported that on (b)(6)2023, a a 25mm amplatzer pfo occluder was chosen for a procedure using a 10f amplatzer trevisio intravascular delivery system.The patient was slated for atrial septal defect (asd) closure.During procedure, the device had a cobra deformation.The deformed device was never released from the delivery cable while inside the patient.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The physician decided to change the device because it was unsafe to used.A new 25mm amplatzer pfo occluder was chosen and completed the procedure.The patient was reported stable.

• Brand Name: AMPLATZER PFO OCCLUDER
• Common Device Name: 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: 18486745
• Report Number: 2135147-2024-00176
• Device Sequence Number: 12559952
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: 00811806011288
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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 Catalogue Number: 9-PFO-025
• Device Lot Number: 9194190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2023
• 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