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

Catalog Number	9-ASD-028
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	08/07/2024
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 a 28mm amplatzer septal occluder was selected for implant on (b)(6) 2024 using a 10f non-abbott delivery sheath.During implant the device took on a cobra shape.The device was not released from the delivery cable.The device was removed from the patient and replaced with a new 30mm amplatzer septal occluder.During implant the device also took on a deformed shape.The device was not released from the delivery cable.The device was removed from the patient.The procedure was postponed.There was some interaction with cardiac structures during the procedure.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 in the procedure.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
An event of device deformity during implant was report.Information from field indicated that there was some interaction with cardiac structures during the procedure.There were no angulations or kinks noted on the delivery system.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.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.
Additional Manufacturer Narrative
H6 type of investigation code 4114 was removed.H6 investigation findings code 3221 was removed.H6 investigation conclusions code 4315 was removed.An event of device deformity during implant was report.The investigation confirmed the device met functional specifications when analyzed at abbott under non-physiological conditions.Information from field indicated that there was some interaction with cardiac structures during the procedure.There were no angulations or kinks noted on the delivery system.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.The cause of the reported incident could not be conclusively determined.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: 20100498
• Report Number: 2135147-2024-04293
• Device Sequence Number: 12678688
• Product Code: MLV
• UDI-Device Identifier: 00811806010212
• UDI-Public: (01)00811806010212(17)250930(10)7685865
• 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: 2024
• Device Explanted Year: 2024
• 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): 11/19/2024

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: 09/30/2025
• Device Catalogue Number: 9-ASD-028
• Device Lot Number: 7685865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 09/30/2024; 11/12/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 10/02/2024; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2020
• 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: 10F COOK MULLIN SHEATH.
• Patient Sex: Unknown