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

Catalog Number	9-PFO-035
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2024
Type of Reportable Event	Malfunction
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 16 march 2024, a 30mm amplatzer pfo occluder was chosen for implant using a 10f amplatzer trevisio intravascular delivery system.During device preparation, there were slight weaves of thread coming off the device.Both the device and delivery system were exchanged.A 35mm amplatzer pfo occluder was chosen for implant.During procedure, the first disc of the device deployed well.Subsequently, there was a disc bulging formation after the second disc was deployed.The device continuously showed bulging after wiggling and light tugging.The device was recaptured and removed from the patient.There was no interaction with cardiac structures and no angulation or kink in the delivery system.Outside of the patient, the device was unable to regain its expected shape.A new 35mm amplatzer pfo occluder was successfully implanted.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported as stable.
Additional Manufacturer Narrative
An event of bulging of disc upon deployment was reported.It was also reported that the device was unable to regain its expected shape outside patient.The device was returned to abbott for investigation and the device met visual and functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.One image from field appeared to show bulbously deployed proximal disc of an occluder device when connected to the delivery cable outside patient.There appeared blood like substance on the distal disc of device.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.
Event or Problem Description
It was reported that on (b)(6) 2024, a 30mm amplatzer pfo occluder was chosen for implant using a 10f amplatzer trevisio intravascular delivery system.During device preparation, there were slight weaves of thread coming off the device.Both the device and delivery system were exchanged.A 35mm amplatzer pfo occluder was chosen for implant.During procedure, the first disc of the device deployed well.Subsequently, there was a disc bulging formation after the second disc was deployed.The device continuously showed bulging after wiggling and light tugging.The device was recaptured and removed from the patient.There was no interaction with cardiac structures and no angulation or kink in the delivery system.Outside of the patient, the device was unable to regain its expected shape.A new 35mm amplatzer pfo occluder was successfully implanted.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported as 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: 19073069
• Report Number: 2135147-2024-01614
• Device Sequence Number: 17307789
• Product Code: MLV
• UDI-Device Identifier: 00811806011301
• UDI-Public: (01)00811806011301(17)270430(10)8463762
• 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: 2024
• Device Explanted Year: 2024
• 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): 05/06/2024

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-035
• Device Lot Number: 8463762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/16/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TREVISIO INTRAVASCULAR DS, 9-ATV10F45/80.
• Patient Sex: Unknown