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

Model Number	9-AVP2-004
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of device embolization 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.Based on the information received, the cause of the reported incident could not be conclusively determined; however, information from the field indicated that a larger, 6 mm, device was implanted.
Event or Problem Description
In (b)(6) 2018, 4 mm amplatzer vascular plug ii was implanted in the patient ductus arterious.The day after implant, the patient presented with symptoms of device embolization.On (b)(6) 2018, percutaneous retrieval of the device was performed and replaced with a 6 mm amplatzer duct occluder ii (lot number: 6277108).The patient is reported to be stable.The user believes they undersized the device.

• 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: 7586952
• Report Number: 2135147-2018-00067
• Device Sequence Number: 2221617
• Product Code: KRD
• UDI-Device Identifier: 00811806010359
• UDI-Public: 00811806010359
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K071125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/11/2018

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: 07/31/2021
• Device Model Number: 9-AVP2-004
• Device Catalogue Number: 9-AVP2-004
• Device Lot Number: 5623873
• 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: 05/14/2018
• Initial Report FDA Received Date: 06/11/2018
• 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