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

Model Number	9-AVP2-022
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of a residual shunt 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 a re-sterilized device was used.Per the instructions for use, 600539-003 version a, "this device was sterilized with ethylene oxide and is for single use only.Do not reuse or resterilize this device.Attempts to resterilize this device can cause a malfunction,insufficient sterilization, or harm to the patient.".
Event or Problem Description
On (b)(6) 2018 a user elected to use a re-sterilized 22mm amplatzer vascular plug ii.The device was implanted and after implant, a residual shunt remained and a 9mm amplater duct occluder (lot number: 6172614) was implanted to decrease the flow.On (b)(6) 2018, a step in the fistula was observed, and again the user elected to use a re-sterilized 12mm amplatzer vascular plug ii (lot number: 5916435) and coils (manufacturer unknown) were used to address the residual shunting.The user elected to use re-sterilized devices even though the site had new devices available.

• 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: 7642129
• Report Number: 2135147-2018-00078
• Device Sequence Number: 1861709
• Product Code: KRD
• UDI-Device Identifier: 00811806010441
• UDI-Public: 00811806010441
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K071125
• 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: Health Professional
• Remedial Action: Patient Monitoring,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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: 07/31/2022
• Device Model Number: 9-AVP2-022
• Device Catalogue Number: 9-AVP2-022
• Device Lot Number: 6085243
• 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: 05/28/2018
• Initial Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 78