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

Model Number	MF SEPTAL OCCLUDER CRIBRIFORM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
The article, ¿treatment experience of percutaneous embolization using multiple-closure embolization for porous atrial septal defect (masd)¿, was reviewed.The research article presents a background of percutaneous embolization for porous atrial septal defect (masd), the number of obturator plugs, closing plugs selection, and the placement procedures treatment required for each individual.The purpose is to report masd treatment experience using multiple-closure plugs in our hospital and to investigate the factors that influenced closure plug selection.Cases were reviewed retrospectively to investigate the number of defect holes, size, distance between holes, indwelling closure plug, relationship with surrounding structures, and presence of residual shunt.[case 2].A 7-year-old girl.A mesh-shaped defect hole containing an accessory hole with an interforaminal distance of 6mm, 3mm posterior to the main foramen of 7mm.First, an amplatzer multifenestrated septal occluder caso-mf) 18mm was placed in the accessory foramen, resulting in a small amount of residual shunt, and a aso 6mm was placed in the main foramen.Residual shunt trivial without interfering with surrounding tissue.The article concluded [ it was considered important to evaluate the relationship between defect pore morphology, size, and surrounding structures when appropriate during treatment.] the primary author reiko kawai, md, and corresponding author of this article is tetsuko ishii, yuta mizuno, tomoe yamagata, kentaro okushi, ichiju sato, and hiromichi nakajima, and (b)(6).
Additional Manufacturer Narrative
As reported in a research article, a patient underwent closure of a porous atrial septal defect with an 18mm amplatzer cribriform occluder and a 6mm amptalzer septal occluder (aso).The cribriform was implanted in the accessory foramen and the aso was implanted in the main foramen.An event of residual shunt was reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review, and no device or additional patient information was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
N/a.

• 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: 14690235
• Report Number: 2135147-2022-00382
• Device Sequence Number: 12456939
• Product Code: MLV
• UDI-Device Identifier: 00811806010281
• UDI-Public: 00811806010281
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MF SEPTAL OCCLUDER CRIBRIFORM
• Device Catalogue Number: 9-ASD-MF-018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 7 YR
• Patient Sex: Female