MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER VASCULAR PLUG 4; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	VASCULAR PLUG 4
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	High Blood Pressure/ Hypertension (1908)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
The article, "transcatheter occlusion of a feeding vessel and pneumonectomy in a newborn with the infantile form of scimitar syndrome", was reviewed.The purpose of this case study: an infantile type of scimitar syndrome (ss) is a rare congenital cardiopulmonary anomaly which can lead to pulmonary hypertension and high mortality in children.A two-stage approach has been proposed for the management.The research article presents a case study of a 10 day old early term infant male weighing 2290 grams from a twin pregnancy.The infant was transferred to the author's hospital due to inferior right-sided pulmonary atelectasis and prolonged dependence on mechanical ventilation (mv).On admission, the patient had signs of heart failure.Echocardiography and ct scan revealed infantile type scimitar syndrome (ss), a huge abnormal systemic supply to the lung from the abdominal aorta, and right lung hypoplasia.It was decided to perform a percutaneous occlusion due to the patient's age, body weight and respiratory problems that may worsen after surgical ligation.Cardiac catheterization via femoral vessels with 4-french was performed under general anesthesia.The massive tortuous anomalous vessel (largest diameter - 6.8 mm; narrowest - 4.3 mm) arising from the right anterior wall of the abdominal aorta supplying blood to a localized region of the right lower lung was occluded with amplatzer vascular plug 4 (9-avp038-007) a continuous heparin infusion was prescribed for 24 hours after the procedure.The control echocardiographic examination 7 days after the procedure revealed elevated pulmonary blood pressure (pg at the patent ductus arteriosus (pda) was measured 17 mmhg) and the presence of residual flow through the avp and scimitar vein.In a second procedure, the pda and the anomalous vessel were closed percutaneously using detachable coils (fig 1e).It considered to perform a pda occlusion with the amplatzer piccolo occluder, but the ductus length was greater than the greatest length between the retention discs.At the end of the procedure, complete vessel occlusion was achieved.The article concluded that percutaneous procedures are safe and effective for occluding anomalous vessels in the neonatal period, but continued heparin use after the procedure could disrupt complete occlusion.Sever right pulmonary hypoplasia led to a very early need for a pneumonectomy.[the primary author is stasa krasic, md, mother and child health institute of serbia, radoja dakica 6-8, beograd 11070, serbia].
Additional Manufacturer Narrative
Literature attachment: transcatheter occlusion of a feeding vessel and pneumonectomy in a newborn with the infantile form of scimitar syndrome.As reported in a research article, an event of residual shunt was reported.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, "transcatheter occlusion of a feeding vessel and pneumonectomy in a newborn with the infantile form of scimitar syndrome", was reviewed.The purpose of this case study: an infantile type of scimitar syndrome (ss) is a rare congenital cardiopulmonary anomaly which can lead to pulmonary hypertension and high mortality in children.A two-stage approach has been proposed for the management.The research article presents a case study of a 10 day old early term infant male weighing 2290 grams from a twin pregnancy.The infant was transferred to the author's hospital due to inferior right-sided pulmonary atelectasis and prolonged dependence on mechanical ventilation (mv).On admission, the patient had signs of heart failure.Echocardiography and ct scan revealed infantile type scimitar syndrome (ss), a huge abnormal systemic supply to the lung from the abdominal aorta, and right lung hypoplasia.It was decided to perform a percutaneous occlusion due to the patient's age, body weight and respiratory problems that may worsen after surgical ligation.Cardiac catheterization via femoral vessels with 4-french was performed under general anesthesia.The massive tortuous anomalous vessel (largest diameter - 6.8 mm; narrowest - 4.3 mm) arising from the right anterior wall of the abdominal aorta supplying blood to a localized region of the right lower lung was occluded with amplatzer vascular plug 4 (9-avp038-007) a continuous heparin infusion was prescribed for 24 hours after the procedure.The control echocardiographic examination 7 days after the procedure revealed elevated pulmonary blood pressure (pg at the patent ductus arteriosus (pda) was measured 17 mmhg) and the presence of residual flow through the avp and scimitar vein.In a second procedure, the pda and the anomalous vessel were closed percutaneously using detachable coils (fig 1e).It considered to perform a pda occlusion with the amplatzer piccolo occluder, but the ductus length was greater than the greatest length between the retention discs.At the end of the procedure, complete vessel occlusion was achieved.The article concluded that percutaneous procedures are safe and effective for occluding anomalous vessels in the neonatal period, but continued heparin use after the procedure could disrupt complete occlusion.Sever right pulmonary hypoplasia led to a very early need for a pneumonectomy.[the primary author is stasa krasic, md, mother and child health institute of serbia, radoja dakica 6-8, beograd 11070, serbia].

• Brand Name: AMPLATZER VASCULAR PLUG 4
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 16900356
• Report Number: 2135147-2023-02007
• Device Sequence Number: 20173229
• Product Code: KRD
• UDI-Device Identifier: 00811806012377
• UDI-Public: 00811806012377
• Combination Product (Y/N): N
• PMA/510(K) Number: K113658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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: VASCULAR PLUG 4
• Device Catalogue Number: 9-AVP038-007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 06/12/2023
• 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: 10 DA
• Patient Sex: Male
• Patient Weight: 2 KG