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

Catalog Number	9-AVP038-007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Summarized patient outcomes/complications of amplatzer vascular plug 4 were reported in a research article in a subject population with multiple co-morbidities including patent ductus arteriosus (pda), severe bronchopulmonary dysplasia (bpd) and pulmonary hypertension (ph).Some of the complications reported were obstruction/occlusion, surgical intervention, hospitalization.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.Information from field indicated that avp 4 was used for transcatheter closure of tubular pda.Please note that per the instructions for use, "the safety and effectiveness of this device for cardiac uses (e.G., cardiac septal occlusion, patent ductus arteriosus, paravalvular leak closures) and neurologic uses have not been established.".
Event or Problem Description
The article, "transcatheter closure of tubular pda with amplatzer plug 4 in preterm infants weighing between 900 and 3,400 g: the pros and cons", was reviewed.The article presented a case study of a patient born at 24 gestational weeks, weighing 2500g at time of intervention with a patent ductus arteriosus (pda).It was reported that on an unknown date, an 7x12.5mm amplatzer vascular plug 4 was implanted.It was reported the pulmonary side of the device "jailed" the left pulmonary artery (lpa) and caused a narrowing of the lpa entrance without restriction of the lpa perfusion.A decision was made to dilate the lpa on an unknown date 4 months after implant procedure.The article concluded implantation of the ap4 using a 4 f 0.38 guide wire-compatible catheter without inserting a long sheath makes the closure of tubular ducts with this device feasible and uncomplicated with a short intervention time.However, the limited sizes with fixed lengths of the ap4 make it unsuitable for ducts wider than 4.5 mm and shorter than the chosen device length, which can increase the risk of significant left pulmonary stenosis.A wide range of plug diameters and lengths is required to accommodate the large and short ducts.[the primary and corresponding author was nathalie mini, department of cardiology, (b)(6) centre, (b)(6) germany, with corresponding email: (b)(6).

• 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: 18066863
• Report Number: 2135147-2023-04858
• Device Sequence Number: 7769194
• Product Code: KRD
• UDI-Device Identifier: 00811806012377
• UDI-Public: 00811806012377
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9-AVP038-007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 11/03/2023
• 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 Sex: Unknown
• Patient Weight: 3 KG