MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER VASCULAR PLUG II; ARTERIAL EMBOLIZATION DEVICE

Model Number	9-AVP2-016
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of cardiac perforation was reported.The results of the investigation are inconclusive since 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.Based on the information received, the cause of the reported incident could not be conclusively determined; however, per ifu 600198-002 ver.A, "the safety and effectiveness of this device for cardiac uses (for example, patent ductus arteriosus or paravalvular leak closures) and neurological uses have not been established.Potential complications include, but are not limited to: death, migration of the device, stroke, or vessel perforation.".
Event or Problem Description
On (b)(6) 2018, a 16mm amplatzer vascular plug ii (avp2) was selected for implant in krichenko type c patent ductus arteriosus (pda).During the procedure, the 16mm avp2 was delivered through an 8f guiding catheter (mach1/boston scientific, type unknown) by a femoral vein puncture and was successfully deployed in the patient's ductus.After deployment of the avp2, there was no deformation of avp2 and the procedure was completed without any issues.Postoperatively, the patient remained fully conscious state and in a stable condition and was transferred to a general ward.On (b)(6) 2018, the patient suddenly had back pain after a meal.The contrast enhanced ct was performed and it revealed that stanford type a aortic dissection was observed peripherally around the deployed avp2.Surgery was immediately performed for ascending aortic replacement, aortic arch replacement, and deployment of a stent graft.The pda was surgically closed.The patient is being controlled under ventilator and his hemodynamic has been stable after re-operative surgery.The cause of the dissection is unknown; however, per report the user considered that the avp2 may have been too large for the defect or the delivery approach from the vein instead of the aorta made it difficult to control the plug which may have damaged the vessel wall.
Additional Manufacturer Narrative
An event of non-cardiac perforation (aortic dissection) was reported.The results of the investigation are inconclusive since 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.Based on the information received, the cause of the reported incident could not be conclusively determined; however, per ifu 600198-002 ver.A, "the safety and effectiveness of this device for cardiac uses (for example, patent ductus arteriosus or paravalvular leak closures) and neurological uses have not been established.Potential complications include, but are not limited to: death, migration of the device, stroke, or vessel perforation.".

• Brand Name: AMPLATZER VASCULAR PLUG II
• Common Device Name: ARTERIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7774627
• Report Number: 2135147-2018-00100
• Device Sequence Number: 19180420
• Product Code: KRD
• UDI-Device Identifier: 00811806010410
• UDI-Public: 00811806010410
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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 Expiration Date: 03/31/2023
• Device Model Number: 9-AVP2-016
• Device Catalogue Number: 9-AVP2-016
• Device Lot Number: 6432792
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 57