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

Model Number	9-ASD-017
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	05/26/2025
Type of Reportable Event	Malfunction
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 a 17mm amplatzer septal occluder was selected for implant using an 8f non-abbott delivery sheath.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 sheath.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays in the procedure.There were no adverse effects to the patient.The patient status was stable.
Event or Problem Description
It was reported on (b)(6) 2025 a 17mm amplatzer septal occluder was selected for implant using an 8f non-abbott delivery sheath.During implant the occluder took on a cobra shape.The occcluder 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 sheath.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays in the procedure.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
An event of device deformity 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 specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information and without the device to analyze, the cause of the reported device deformation could not be determined.It is possible that the procedural conditions could have contributed to the device deformation.However, this can not be conclusively determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Please note that per the instruction for use (ifu), the recommended sheath size to be used with 17 mm amplatzer septal occluder is 7f.Codes removed: type of investigation: 4118 types of investigation not yet determined.Investigation findings: 3233 results pending completion of investigation.Investigation conclusions: 11 conclusions not yet available.
Additional Manufacturer Narrative
An event of device deformity was reported.The device was returned to abbott for investigation and the device was visually observed, the device was returned with a broken sewing thread.Due to this the functional testing was precluded.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The sewing process includes in-process inspections to detect structural anomalies such as wire bunching or unacceptable lipping, which could lead to deformation.Additionally, the final inspection process involves a 100% visual inspection and a controlled deployment test, where defects like ¿cobra¿ are explicitly defined and rejected.Therefore, this complaint is classified as not manufacturing related, and no further manufacturing investigation is required for these events.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that per the instruction for use (ifu), the recommended sheath size to be used with 17 mm amplatzer septal occluder is 7f.

• 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: 22285679
• Report Number: 2135147-2025-03275
• Device Sequence Number: 12839601
• Product Code: MLV
• UDI-Device Identifier: 00811806010144
• UDI-Public: (01)00811806010144(17)270331(10)8421672
• 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,Followup
• Report Date (Section B): 12/12/2025

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-017
• Device Catalogue Number: 9-ASD-017
• Device Lot Number: 8421672
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 09/08/2025; 12/04/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/16/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8F MULLINS SHEATH.
• Patient Sex: Unknown