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

Model Number	9-ASD-009
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date in 2025 in (b)(6), the patient received two mitraclips to treat mitral regurgitation.The patient was hospitalized for intervention on (b)(6) 2025 due to decompensated heart failure resulting from recurrent mr grade 4+ and mitral pressure gradient 7mmhg.Both clips were in place but the lateral clip showed movement and tilt.A mitraclip xt was successfully placed lateral of the two pre-exisiting clips, reducing mr to grade 2-3 and pressure gradient to 6mmhg.An additional mitraclip nt was attempted to be placed medial of the pre-existing clips - grasp was successful and reduced mr significantly, but gradient increased to 14mmhg.It was decided to remove this clip.Gradient went back down to 6mmhg.There were no issues with the nt clip.After the successful mitral intervention, it was decided to treat the iatrogenic atrial septal defect still remaining from the original mitraclip procedure.A 9mm amplatzer atrial septal defect (asd) occluder with a 10f trevisio delivery sheath was attempted to be implanted.During deployment the occluder deformed into a cobra shape.The occluder was removed, and the deformation still remained outside the patient.Physician manipulated the occluder and it returned to normal shape.The same occluder was then implanted successfully without any deformation.There were no adverse patient effects or clinically significant delay.
Additional Manufacturer Narrative
Na.The device remains implanted in patient.The device will not be returned for evaluation.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 an unknown date in 2025, the patient received two mitraclips to treat mitral regurgitation.The patient was hospitalized for intervention on (b)(6) 2025 due to decompensated heart failure resulting from recurrent mr grade 4+ and mitral pressure gradient 7mmhg.Both clips were in place but the lateral clip showed movement and tilt.A mitraclip xt was successfully placed lateral of the two pre-exisiting clips, reducing mr to grade 2-3 and pressure gradient to 6mmhg.An additional mitraclip nt was attempted to be placed medial of the pre-existing clips - grasp was successful and reduced mr significantly, but gradient increased to 14mmhg.It was decided to remove this clip.Gradient went back down to 6mmhg.There were no issues with the nt clip.After the successful mitral intervention, it was decided to treat the iatrogenic atrial septal defect still remaining from the original mitraclip procedure.A 9mm amplatzer atrial septal defect (asd) occluder with a 10f trevisio delivery sheath was attempted to be implanted.During deployment the occluder deformed into a cobra shape.The occluder was removed, and the deformation still remained outside the patient.Physician manipulated the occluder and it returned to normal shape.The same occluder was then implanted successfully without any deformation.There were no adverse patient effects or clinically significant delay.
Additional Manufacturer Narrative
An event of device deformity and improper or incorrect procedure or method was reported.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 defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the information received, the cause of the reported device deformity could not be conclusively determined.The reported improper or incorrect procedure or method is related to the device being implanted after the device did not conform to its original configuration and was already recaptured and redeployed with the deformation persisting.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 24299880
• Report Number: 2135147-2026-00758
• Device Sequence Number: 9332783
• Product Code: MLV
• UDI-Device Identifier: 00811806010069
• UDI-Public: (01)00811806010069(17)270930(10)8726840
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 02/24/2026

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-009
• Device Catalogue Number: 9-ASD-009
• Device Lot Number: 8726840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2022
• 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
• Patient Sex: Unknown