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

Model Number	9-ASD-018
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	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2025 an 18mm amplatzer septal occluder was selected for implant using a 9f amplatzer torqvue delivery system.During implant the occluder took on a cobra shape.The occluder was not released from the delivery cable and was removed from the patient.There were no interactions with cardiac structures.There were no angulations or kinks noted on the delivery system.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays to the procedure.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on (b)(6) 2025 an 18mm amplatzer septal occluder was selected for implant using a 9f amplatzer torqvue delivery system.During implant the occluder took on a cobra shape.The occluder was not released from the delivery cable and was removed from the patient.There were no interactions with cardiac structures.There were no angulations or kinks noted on the delivery system.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays to the procedure.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
An event of device deformity could not be confirmed.The investigation at abbott found that there were no visible anomalies noted.The state of the returned component, due to the fracture damage, functional testing was precluded.The device was sent to science & technology lab (s&t) for further analysis.The device was further investigated by cross-functional teams at abbott, and it was found that the observed wire pitting and fractures are most consistent with localized corrosion accelerated by saline exposure post-procedure, rather than a systemic raw material or manufacturing related issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.During final inspection amplatzer¿ asd occluder undergo multiple wire-focused evaluations.These inspections are specifically designed to detect structural anomalies such as broken wires, wire protrusions (lipping), cobra-type deformation, tilting, and braid non-uniformity, ensuring that any device exhibiting wire-related defects is identified and rejected prior to release.If they had existed prior to shipment, a broken wire would have been detected.Therefore, there is no evidence to indicate that the event involving the unit with a broken wire was caused as part of the manufacturing process.The root cause of the damaged wires could not be conclusively determined.The cause of reported deformation could not be conclusively determined.The observed deformation is compatible with overstress of wires and could result from the same event or from later handling.Based on the evidence and data provided, the findings do not support a manufacturing origin and are consistent with post-abbott handling damage; therefore, the root cause of the complaint remains inconclusive.There were no complaints associated with any other devices from the lot.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: 22329451
• Report Number: 2135147-2025-03416
• Device Sequence Number: 9418246
• Product Code: MLV
• UDI-Device Identifier: 00811806010151
• UDI-Public: (01)00811806010151(17)281231(10)10141228
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 02/26/2026

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-018
• Device Catalogue Number: 9-ASD-018
• Device Lot Number: 10141228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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: 9F AMPLATZER TORQ DS[9-ITV09F45/80, LOT: 10416208]
• Patient Age: 33 YR
• Patient Sex: Female