MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number	9-ASD-MF-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	12/17/2024
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 on (b)(6) 2024, an 18mm amplatzer cribriform occluder was selected for implant using an 8f amplatzer trevisio intravascular delivery system.During procedure, excessive separation between the discs and a bulging left atrial disc was observed.There were no interactions with cardiac structures during deployment and no angulation/kink was observed with the deliver system.The occlude was never released from the delivery cable while inside the patient and it was exchanged for a new 28mm amplatzer septal occluder, which was successfully implanted.The patient was reported to be in good condition.
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 deformity could not be conclusively determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21124179
• Report Number: 2135147-2025-00245
• Device Sequence Number: 18027103
• Product Code: MLV
• UDI-Device Identifier: 00811806010281
• UDI-Public: (01)00811806010281(17)250131(10)7406116
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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 Expiration Date: 01/31/2025
• Device Catalogue Number: 9-ASD-MF-018
• Device Lot Number: 7406116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2020
• 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
• Patient Sex: Unknown