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

Model Number	SEPTAL OCCLUDER
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	05/23/2022
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.
Event or Problem Description
It was reported that on 23 may 2022, a 15mm amplatzer septal occluder was chosen for procedure using a 12f amplatzer trevisio intravascular delivery system.During procedure, the device deployed as a cobra deformation.There was an interaction with the atrial septum during deployment.After a series of attempts, the decision was made to replace the device.A 16mm amplatzer septal occluder was successfully implanted instead.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.There was no angulation or kink noticed in the delivery system.
Additional Manufacturer Narrative
An event of cobra shaped deformity could not be confirmed.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 specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the amplatzer septal occluder instructions for use, (b)(6).Revision a table t1: the correct size delivery system for a 15mm septal occluder is a 7fr.Information from the field indicated a 12fr sheath was used.Na.

• 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: 14834261
• Report Number: 2135147-2022-00441
• Device Sequence Number: 11357744
• Product Code: MLV
• UDI-Device Identifier: 00811806010120
• UDI-Public: 00811806010120
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 08/17/2022

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: 03/31/2024
• Device Model Number: SEPTAL OCCLUDER
• Device Catalogue Number: 9-ASD-015
• Device Lot Number: 6940290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2019
• 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 DS, 9-ATV12F45/80
• Patient Age: 40 YR
• Patient Sex: Male