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

Catalog Number	9-ASD-019
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Perforation (2001); Cardiac Tamponade (2226)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, a 19mm amplatzer septal occluder was implanted in a patient.During surgery perforation was described by a hole 1mm punctiform near the non coronary sinus.It is unknown if any intervention was performed at that time.On (b)(6) 2024, the patient had aorta perforation erosion post procedure.The patient was transferred to surgery to close hole in the aorta.The patient is stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of patient-device incompatibility related tissue erosion and perforation 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.Information from the field indicated that the patient had aorta perforation erosion post procedure.The patient was transferred to surgery to close hole in the aorta.Perforation was described by a hole 1mm punctiform near the non-coronary sinus during surgery.Based on the information received, the cause of the reported patient-device incompatibility related tissue erosion and perforation could not be determined.The reported surgical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Additional Manufacturer Narrative
An event of patient-device incompatibility, perforation, and cardiac tamponade 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.Information from the field indicated that the patient had aorta perforation erosion post procedure.The patient was transferred to surgery to close hole in the aorta.Perforation was described by a hole 1mm punctiform near the non-coronary sinus during surgery.Based on the information received, the cause of the reported patient-device incompatibility related tissue erosion and tissue damage, perforation, and cardiac tamponade could not be determined.The reported surgical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 19751399
• Report Number: 2135147-2024-03437
• Device Sequence Number: 8850496
• Product Code: MLV
• UDI-Device Identifier: 00811806010168
• UDI-Public: 00811806010168
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2024

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 Catalogue Number: 9-ASD-019
• Device Lot Number: 8572968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 07/25/2024; 09/19/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/02/2024; 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male