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

Model Number	9-PLUG-014
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Death (1802)
Date of Event	09/03/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
An event of embolization and patient death 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, information from the field stated that the user did not believe the patient death was attributable to the amplatzer vascular plug.The patient had undergone a tavi procedure and the avp was implanted and embolized during that procedure.
Event or Problem Description
On (b)(6) 2018, a 14mm amplatzer vascular plug (avp) was selected to close the carotid artery during a tavr procedure.After the plug was released, the device moved to the aorta.A 14mm amplatzer vascular plug 2 (lot number: 4645198) was then placed and successfully embolized the target vessel and the tavr procedure continued.Following the tavr procedure, the patient was taken to the icu for recovery.Later that night, the patient was brought back to the operating room due to a tavr procedural complication and did not survive.The user did not suggest the death or complication was due to either vascular plugs involved.The user's only concern was the migration of the 14mm avp to the aorta.Patient's information (e.G.Age, weight, gender, ethnicity, race, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.

• Brand Name: AMPLATZER VASCULAR PLUG
• Common Device Name: ARTERIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7908482
• Report Number: 2135147-2018-00165
• Device Sequence Number: 13876304
• Product Code: KRD
• UDI-Device Identifier: 00811806011493
• UDI-Public: 00811806011493
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K031810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2018

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: 09/30/2021
• Device Model Number: 9-PLUG-014
• Device Catalogue Number: 9-PLUG-014
• Device Lot Number: 5689240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 09/25/2018
• 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: Death; Hospitalization; Required Intervention