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

Model Number	PFO OCCLUDER
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022 , a 18mm amplatzer patent foramen ovale (pfo) occluder was selected for procedure.During device prepartion, the amplatzer pfo occluder was noted to have an exposed thread.The decision was made to cut off the thread and to continue to the 18mm amplatzer pfo occluder for implant.During procedure, both discs of the occluder exhibited a ball shape without resolution.The device was removed from the patient prior to release from the delivery cable.There was no interaction with cardiac structures during deployment.There was no angulation or kink noticed in the delivery system a second 18mm amplatzer pfo occluder was used as a replacement device and implanted successfully.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2022, a 18mm amplatzer patent foramen ovale (pfo) occluder was selected for procedure.During device preparation, the amplatzer pfo occluder was noted to have an exposed thread.The decision was made to cut the thread and continue the procedure with the 18mm amplatzer pfo occluder.During procedure, both discs of the occluder exhibited a ball shape without resolution.The device was removed from the patient prior to release from the delivery cable.There was no interaction with cardiac structures during deployment.There was no angulation or kink noticed in the delivery system.A second 18mm amplatzer pfo occluder was used as a replacement device and implanted successfully.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.The patient was stable at the time of report.Subsequent to the initially filed report, additional information was received and a correction needs to be made.The deformation of the two disc of the 18mm amplatzer pfo occluder were noted prior to being introduced to the delivery system or patient.There was no patient contact made with the deformed 18mm amplatzer pfo occluder.The 18mm amplatzer pfo occluder was replaced with anogther one of the same size after the deformation was noted.
Additional Manufacturer Narrative
An event of the device deploying deformed and a thread being present sticking out of the device was reported.One image was received from the field, which appeared to show a sewing knot sticking out near the edge of the occluder.A returned device 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 defined manufacturing 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 regards to manufacture design or labeling.

• 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: 15126395
• Report Number: 2135147-2022-00595
• Device Sequence Number: 6604267
• Product Code: MLV
• UDI-Device Identifier: 00811806011271
• UDI-Public: 00811806011271
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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 Model Number: PFO OCCLUDER
• Device Catalogue Number: 9-PFO-018
• Device Lot Number: 8235809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2021
• 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