MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER DUCT OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Catalog Number	9-PDA-007
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Fatigue (1849); Movement Disorder (4412)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported in a research article, "redo aortic valve replacement for an incorrectly-sized rapid deployment valve", a 64-year-old male patient with a history of hypertension, epilepsy, gastroesophageal reflux disease, bicuspid aortic valve stenosis, and a 56 mm ascending aortic aneurysm that previously underwent surgical aortic valve replacement surgery with a #25 intuity bioprosthetic valve with a #38 hemashield dacron graft underwent implantation of a 12-10mm amplatzer duct occluder was chosen for an off label use to treat moderate paravalvular leak (pvl) associated with the intuity valve accompanied with worsening fatigue and hemolytic anemia.At an unknown date three years post-intervention, the patient presented with fatigue and dizziness.Transthoracic echocardiography revealed severe pvl and mean gradient of 16.5mmhg across the aortic valve.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
The article, "redo aortic valve replacement for an incorrectly-sized rapid deployment valve", was reviewed.The article presented a case study of a 64-year-old male patient with a history of hypertension, epilepsy, gastroesophageal reflux disease, bicuspid aortic valve stenosis, and a 56 mm ascending aortic aneurysm.It was reported the patient previously underwent surgical aortic valve replacement surgery with a #25 intuity bioprosthetic valve with a #38 hemashield dacron graft.It was reported that on an unknown date, a 12-10mm amplatzer duct occluder was chosen for an off label use to treat moderate paravalvular leak (pvl) associated with the intuity valve accompanied with worsening fatigue and hemolytic anemia.After implant of the occluder across the pvl, it was noted there was complete elimination of pvl it was then reported on an unknown date three years post-intervention, the patient presented with fatigue and dizziness.Transthoracic echocardiography revealed severe pvl and mean gradient of 16.5mmhg across the aortic valve.A decision was made to redo aortic valve replacement.During reintervention, it was noted the occluder had failed to cover the gap between the subvalvular skirt and ventricular wall caused by the undersized intuity valve.The valve was explanted and replaced with a #27 edwards magna ease bioprosthetic valve sewing ring.The article concluded this case demonstrates a failed avr due to incorrect sizing of an intuity valve, resulting in severe pvl refractory to transcatheter repair options.A redo-sternotomy and surgical avr was performed with excellent outcomes.Preoperative images should be reviewed and analyzed to aid in the selection of the optimal intuity valve size for implantation.[(b)(6)].

• Brand Name: AMPLATZER DUCT OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• 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: 18321906
• Report Number: 2135147-2023-05479
• Device Sequence Number: 7035494
• Product Code: MAE
• UDI-Device Identifier: 00811806011141
• UDI-Public: 00811806011141
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-PDA-007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2023
• 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; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male