MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER POST-INFARCT VSD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	POST INFARCT MUSCULAR VSD OCCLUDER
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, a 20mm amplatzer post-infarct ventricular septal defect (vsd) occluder was utilized with a 10f amplatzer trevisio intravascular delivery system.Upon deployment, the left disc deformed in a cobra shape.The device was recaptured and re-deployed twice and then the left disc re-formed to its expected shape.The rest of the device was deployed from the delivery system, and the right disc was elongated, compressed, and deformed.The right ventricular disc may have been constrained within right ventricular trabeculation.In attempting to recapture the right disk the device slipped through the defect into the right ventricle.The device was removed and a replacement 22mm amplatzer post-infarct vsd occluder.The patient had several runs of ventricular tachycardia requiring pacing during the procedure.They all resolved quickly and did not prolong the procedure and did not require any additional intervention.There was no report adverse patient effects or clinically significant delay.The patient was reported as 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 device deformity was reported.One image was received from the field appearing to show device presenting deformation during deployment inside the patient.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The investigation confirmed that the device met functional and visual specifications when analyzed at abbott under non-physiological conditions.Based on the information received, the root cause of the reported incident could not be conclusively determined but may have been contributed to by the interaction of the device with cardiac structures.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER POST-INFARCT VSD 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: 17159829
• Report Number: 2135147-2023-02663
• Device Sequence Number: 14850512
• Product Code: MLV
• UDI-Device Identifier: 05415067028129
• UDI-Public: 05415067028129
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023

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: 01/31/2026
• Device Model Number: POST INFARCT MUSCULAR VSD OCCLUDER
• Device Catalogue Number: 9-VSDMPIHDE-020
• Device Lot Number: 7838266
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2021
• 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: AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 122 KG