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

Model Number	Duct Occluder II
Medical Device Problem Codes	Off-Label Use (1494); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Renal Failure (2041)
Date of Event	02/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: (b)(6) - paradigm, patient site id: (b)(6).It was reported that on 02 february 2023, an 8x4mm amplatzer valvular plug and a 6mmx4mm amplatzer duct occluder ii were successfully implanted in a patient.The patient was placed under general anesthesia for procedure.The patient had remained hemodynamically stable throughout the implant procedure.The plug and occluder were implanted for the closure of a cardiac paravalvular leak (pvl).The plug and occluder were both sized using transesophageal echocardiography measurements.On (b)(6) 2023, the patient was re-admitted due to the patient's reporting consistently dark urine and a small streak of blood every time during urination (hematuria).A transesophageal echocardiogram was performed and revealed a severe residual shunt anterolateral to the 8x4mm amplatzer valvular plug and posteromedial to the 6mmx4mm amplatzer duct occluder ii.On (b)(6) 2023, an x-ray was performed and revealed increased right and left kidney echogenicity, a mildly distended bladder with mild circumferential bladder wall thickening, and a anechoic cystic structure posterolateral to the urinary bladder.On (b)(6) 2023, a computed tomography scan was also performed and revealed two intramuscular lipomas.On (b)(6) 2023, the patient was transfused with leuko-reduced red blood cells due to hemolysis.On (b)(6) 2023, the patient underwent a percutaneous intervention for closure of the residual shunt.The event resulted in surgical and unexpected medical interventions and prolonged hospitalization.The patient did not experience any notable dizziness, lightheadedness, difficulty urinating, chest pain or dyspnea.The patient's renal function continues to the monitored and the 8x4mm amplatzer valvular plug and 6mmx4mm amplatzer duct occluder ii remain implanted.The patient is currently recovering, following the percutaneous intervention.The cause of the patient's worsening renal function is attributed to the hemolysis that occurred as a result of the residual shunt.
Additional Manufacturer Narrative
An event of residual shunt, hemolysis, paravalvular leak, and renal failure was reported.A returned device assessment could not be performed as the device remains implanted and 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.It was believed by the field that cause of the patient's worsening renal function is attributed to the hemolysis that occurred as a result of the residual shunt.Based on the information, the cause of the reported event could not be conclusively determined.Please note, per the intended use arten600196059 revision b "the amplatzer¿ duct occluder ii is a percutaneous transcatheter occlusion device intended for the non-surgical closure of patent ductus arteriosus.".

• Brand Name: AMPLATZER DUCT OCCLUDER II
• 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: 16943206
• Report Number: 2135147-2023-02141
• Device Sequence Number: 6850650
• Product Code: MAE
• UDI-Device Identifier: 00811806011257
• UDI-Public: 00811806011257
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2023

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 Model Number: Duct Occluder II
• Device Catalogue Number: 9-PDA2-06-04
• Device Lot Number: 8442836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2022
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American