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

Model Number	9-ASD-030
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	03/02/2022
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.The additional amplatzer septal occluder lot 7170020 is filed under separate manufacturer reference number: 2135147-2022-00104-00.
Event or Problem Description
It was reported, a 30mm amplatzer septal occluder (7023673) was chosen for procedure with a 12f amplatzer trevisio intravascular delivery system.During procedure, upon deployment of the device, the left disc of the device presented in a cobra shape deformation.The device was retrieved and a new, 32mm amplatzer septal occluder (7170020) was deployed using the same delivery system.This device also presented with a cobra shape deformation of the left disc.The device was re-sheathed twice.The device was removed and exchanged with a 34 mm amplatzer septal occluder (7232844).The 34mm amplatzer septal occluder was determined a mis-sizing, the device was too big therefore never implanted.The patient remained hemodynamically stable throughout the procedure.Ultimately no device was implanted.
Additional Manufacturer Narrative
An event of device deformity was reported.The device was returned to abbott for investigation and the device met 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.No indication of a lot related issue was found.The cause of the reported event could not be conclusively determined.Please note, per the instructions for use, states the minimum recommended size delivery system for use with a 30 mm amplatzer septal occluder is an 10f.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13911981
• Report Number: 2135147-2022-00105
• Device Sequence Number: 14522183
• Product Code: MLV
• UDI-Device Identifier: 05415067019332
• UDI-Public: 05415067019332
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000039
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2022

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 Expiration Date: 04/30/2024
• Device Model Number: 9-ASD-030
• Device Catalogue Number: 9-ASD-030
• Device Lot Number: 7023673
• 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: 03/02/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2019
• 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 DS, LOT 7500550
• Patient Sex: Female