MAUDE Adverse Event Report: Abbott Medical Amplatzer Septal Occluder; Transcatheter Septal Occluder

Model Number	9-ASD-022
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	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a 22mm amplatzer septal occluder was chosen for implant using a 9f amplatzer torqvue delivery system.During the procedure, it was noted that the occluder did not take proper shape reulting in bulbous formation.It was reported that the physician recaptured left atrial disc of the device into the delivery sheath, then unsheathed to left atrial disc a second time.The left atrial disc maintained it's odd shape.The deformed device was never released from the delivery cable while inside the patient.There was no angulation or kink noted in the delivery system.There was no interaction with cardiac structures during deployment.The implanter decided to replace the device.A new 22mm amplatzer septal occluder(lot:10912084) was used as replacement device to complete the procedure.There was nothing that occurred during unpackaging or prepping the device that would have affected the shape of the left atrial disc.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

• 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 ; +1(651)756-5400
• MDR Report Key: 50801819
• Report Number: 2135147-2026-06272
• Device Sequence Number: 20981645
• Product Code: MLV
• UDI-Device Identifier: 00811806010182
• UDI-Public: (01)00811806010182(17)290930(10)10579476
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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 Model Number: 9-ASD-022
• Device Catalogue Number: 9-ASD-022
• Device Lot Number: 10579476
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2024
• 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 TorqVue 45 9-ITV09F45/80 lot# 10791040
• Patient Sex: Unknown