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

Catalog Number	9-PFO-025
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	04/29/2024
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 (b)(6) 2024, a 25mm amplatzer pfo occluder was selected for implant using a 10f amplatzer trevisio intravascular delivery system.During implant, the first disc was deployed without issue.However, during deployment of the second disc, disc bulging was observed.Light tugging was performed, but the deformation persisted and the device was retrieved and removed from the patient prior to release from the delivery cable.There was no angulation or kink noticed with the delivery system and no report of interaction with any cardiac structures during deployment.A new 25mm amplatzer pfo occluder was successfully implanted.The patient was reported to be in stable condition.
Event or Problem Description
It was reported that on 29 april 2024, a 25mm amplatzer pfo occluder was selected for implant using a 10f amplatzer trevisio intravascular delivery system.During implant, the first disc was deployed without issue.However, during deployment of the second disc, disc bulging was observed.Light tugging was performed, but the deformation persisted and the device was retrieved and removed from the patient prior to release from the delivery cable.There was no angulation or kink noticed with the delivery system and no report of interaction with any cardiac structures during deployment.A new 25mm amplatzer pfo occluder was successfully implanted.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
An event of device deformity was reported.A returned device inspection 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.Information from the field indicated that there was no anatomical interference, there was no angulation or kink in the delivery system upon deployment and a 10f size delivery system was used.Based on the information received, the cause of the reported device deformity 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: 19363040
• Report Number: 2135147-2024-02301
• Device Sequence Number: 3785455
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: (01)00811806011288(17)280731(10)9194190
• 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): 06/11/2024

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): Initial
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TREVISIO INTRAVASCULAR DS, 9-ATV10F45/80.
• Patient Sex: Unknown