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

Model Number	9-ASD-016
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, a 16mm amplatzer septal occluder was chosen for implant.During the procedure, it was reported that the device was not able to deploy well and was not fully released from the delivery system.It was decided that the product would be replaced using a 18mm non-abbott occluder.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.
Additional Manufacturer Narrative
An event of the device not being able to deploy well was reported.Device deformation did not occur, but the cardiac structures had interaction with the device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that the device went too deep into the rim of the aorta and that the device was not meant to make contact.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6: device code 1254 was removed.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: an 8f amplatzer trevisio intravascular delivery system was used to deliver the device.There was no noticed angulation or kinks in the delivery system.When attempting to implant the device, the right atrium disk went deeper than anticipated and interacted with the rim of the aorta.There was no resistance noted when attempting to implant the device.No deformation was reported.The replacement device did not make contact with the aorta.No additional information was provided.

• 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: 15497261
• Report Number: 2135147-2022-01394
• Device Sequence Number: 12218549
• Product Code: MLV
• UDI-Device Identifier: 05415067019240
• UDI-Public: 05415067019240
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/05/2022

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: 01/31/2024
• Device Model Number: 9-ASD-016
• Device Catalogue Number: 9-ASD-016
• Device Lot Number: 6868112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2019
• 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 INTRAVASCULAR DELIVERY SYSTEM
• Patient Sex: Unknown