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

Model Number	PFO OCCLUDER
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023, a 12mm amplatzer septal occluder was chosen for implant on an atrial septal defect (asd) using an 8f amplatzer trevisio intravascular delivery system.The patient had a complex anatomy due to a congenital malformation of cardiac chambers and connections.The 12mm amplatzer septal occluder was attempted to be placed, but the device did not provide a complete closure, so it was removed prior to release from the delivery cable.There was no allegation against the sizing of the 12mm amplatzer septal occluder.Next, a 6mm by 6mm amplatzer duct occluder ii was chosen to minimize the interaction of the disc with the atrial wall.The result was unsatisfactory with incomplete closure, so it was removed prior to release from the delivery cable.There was no allegation against the sizing of the 6mm by 6mm amplatzer duct occluder ii.Then, a 18mm amplatzer pfo occluder was deployed and released.Due to the complex anatomy, the device did not sit as expected on the septum upon release, and closure was not completely achieved.The exact origin of the leak could not be determined.The device was successfully snared and retrieved from the patient.A 20mm non-abbott septal occluder was then attempted for implant.The device was still not able to achieve complete closure due to complex anatomy, but it was released and left in place.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported as discharged.
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 residual shunt was reported.A returned device assessment could not be performed as the device remains implanted and 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.Field indicated that due to the complex anatomy, the device did not sit as expected on the septum upon release, and closure was not completely achieved which could have contributed to the reported event.Based on the information received, thecause of the reported incident could not be conclusively determined.

• 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: 17282513
• Report Number: 2135147-2023-02932
• Device Sequence Number: 5173072
• Product Code: MLV
• UDI-Device Identifier: 00811806011271
• UDI-Public: 00811806011271
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PFO OCCLUDER
• Device Catalogue Number: 9-PFO-018
• Device Lot Number: 8538559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 96 KG