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

Model Number	9-ASD-022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Heart Block (4444)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The article, "rescue atrial septal defect closure with the new gore® cardioform atrial septal defect occluder" was reviewed.It was reported that on an unknown date a 22mm amplatzer septal occluder was selected for implantation.Prior to the procedure, the patient was diagnosed with a right bundle branch block by electrocardiogram (ekg).A transthoracic echocardiogram (tte) showed that the defect was 14mm.The device was successfully implanted.24 hours after the procedure, the patient developed a complete heart block.They administered methylprednisolone therapy, and then the device was removed using a goose neck catheter.The patient recovered and had normalized rhythm.A few months later, a second attempt at sizing was done, and it was found that the defect was 23-24mm.A 44mm atrial septal defect (asd) closure device was selected and successfully implanted.At the six month follow up, the patient was reported to be stable and normal sinus rhythm.No additional information was provided.The primary author of the article is alessandra pizzuto, md, department of pediatric cardiology and guch unit, heart hospital ¿g.Pasquinucci¿, national research council tuscany region ¿g.Monasterio¿, massa, italy.The correspondence author of the article is giuseppe santoro, md, via camillo sorgente, 31, 84125 ¿ salerno, italy.With the corresponding e-mail: santoropino@tin.It.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Summarized patient outcomes/complications of amplatzer septal occluder were reported in a research article in a subject population with large atrial septal defect, incomplete right bundle branch block co-morbidities.Some of the complications reported were right bundle branch block and a complete heart block; these complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.

• 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): 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: 15840669
• Report Number: 2135147-2022-02149
• Device Sequence Number: 6901775
• Product Code: MLV
• UDI-Device Identifier: 05415067019295
• UDI-Public: 05415067019295
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 01/30/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-022
• Device Catalogue Number: 9-ASD-022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 01/30/2023
• 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: Required Intervention
• Patient Age: 7 YR
• Patient Sex: Female
• Patient Weight: 27 KG