MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER VASCULAR PLUG II; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	9-AVP2-014
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a 14mm amplatzer vascular plug ii was selected for implanted to embolize the graft from the aorta into the lvad (mdt heartmate).The plug was positioned and optimally released.The patient had a high quick and the blood clotting was optimized; however, after 60 minutes the vessel was not completely embolized after 60 minutes.The patient was then brought to surgery.No adverse patient consequences were reported.
Additional Manufacturer Narrative
An event of the device incompletely embolizing a graft from the aorta into the lvad was reported.The results of the investigation are inconclusive since the device 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 at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER VASCULAR PLUG II
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9250742
• Report Number: 2135147-2019-00355
• Device Sequence Number: 2310770
• Product Code: KRD
• UDI-Device Identifier: 00811806010403
• UDI-Public: 00811806010403
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: 03/31/2024
• Device Model Number: 9-AVP2-014
• Device Catalogue Number: 9-AVP2-014
• Device Lot Number: 6959794
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 11/05/2019
• 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: Required Intervention