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

Model Number	9-AVP2-022
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Embolism (1829); Tissue Damage (2104); Mitral Perforation (2512)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of off label use of the amplatzer vascular plug ii for paravalular leakage and embolization of the device was reported.A more comprehensive assessment could not be performed as 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.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the instructions for use, arten600038211 revision a "the safety and effectiveness of this device for cardiac uses (for example, patent ductus arteriosus or paravalular leak closures) and neurological uses have not been established.".
Event or Problem Description
On (b)(6) 2020, a patient with paravalvular leak (pvl) on the mitral valve had a procedure with amplatzer devices.The patient had endocarditis of the mitral valve, coronary artery disease, moderate calcification, and patient anatomy with little tortuosity.It was observed that the tissue around the leak was friable.The physician attempted to close the leak with an amplatzer septal occluder (aso) (lot # unknown), it was mis-sized and exchanged with another aso (lot # unknown).The second aso was mis-sized exchanged for an amplatzer vascular plug.The amplatzer vascular plug was mis-sized too small and exchanged for a 22mm amplatzer vascular plug 2.The device was released and implanted.However, due to the patient anatomy and the tissue around the defect, the tissue around the defect tore and the plug embolized to the right ventricle.The plug was snared and pulled into the aorta and the iliac.A surgical intervention was then performed to remove the device.The future management of the pvl was not determined.The patient is currently stable and no consequences was reported post device removal.

• 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: 10181891
• Report Number: 2135147-2020-00296
• Device Sequence Number: 11641192
• Product Code: KRD
• UDI-Device Identifier: 00811806010441
• UDI-Public: 00811806010441
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K0701699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2020

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: 08/31/2023
• Device Model Number: 9-AVP2-022
• Device Catalogue Number: 9-AVP2-022
• Device Lot Number: 6656933
• 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: 06/09/2020
• Initial Report FDA Received Date: 06/22/2020
• 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
• Patient Age: 81 YR
• Patient Weight: 71