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

Model Number	9-AVP2-018
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2019, an off label avp2 was attempted in the mitral valve position between 2 previous mitraclip implanted however, the patient was not an ideal mitraclip candidate but was non- surgical and had no other alternatives but to attempt mitraclip.Following the procedure, severe mr (mitral regurgitation) remained and the patient remained in a near cardiogenic shock state.On (b)(6) 2019, there was an attempt to place an 22mm amplatzer vascular plug ii between the 2 mitraclip.A plug (batch number: 701807) was deployed between the clips however, dislodged prior to being released.The plug was re-sheathed and removed and was exchanged for 18mm amplatzer vascular plug ii (batch number: 6996646).The second plug was attempted to implanted but was unsuccessfully placed.The 22mm amplatzer vascular plug ii (batch number: 701807) was re-introduced and deployed and appeared to be in good position.An echocardiogram was performed and a decrease in mr was noted however, increase in the patient's blood pressure was reported.With in minutes of successful deployment of the 18mm amplatzer vascular plug ii the device embolized into the left atrium (la) and it was decided to leave the device in the la.Post procedure the patient was transferred into palliative care in the ccu (cardiac care unit).Manufacturer report number:2135147-2019-00272.
Additional Manufacturer Narrative
An event of off-label use of the amplatzer vascular plug ii and unsuccessful placement of that device 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.Please note, per the instructions for use, artmt100092325 revision b "the safety and effectiveness of this device for cardiac uses(for example, patent ductus arterious or paravalvular leak closures) and neurological uses have not been established.
Event or Problem Description
Correction: on (b)(6) 2019, an off label avp2 was attempted in the mitral valve position between 2 previous mitraclip implanted however, the patient was not an ideal mitraclip candidate but was non- surgical and had no other alternatives but to attempt mitraclip.Following the procedure, severe mr (mitral regurgitation) remained and the patient remained in a near cardiogenic shock state.On (b)(6) 2019, there was an attempt to place an 22mm amplatzer vascular plug ii between the 2 mitraclip.A plug (batch number: 701807) was deployed between the clips however, dislodged prior to being released.The plug was re-sheathed and removed and was exchanged for 18mm amplatzer vascular plug ii (batch number: 6996646).The second plug was attempted to implanted but was unsuccessfully placed.The 22mm amplatzer vascular plug ii (batch number: 701807) was re-introduced and deployed and appeared to be in good position.An echocardiogram was performed and a decrease in mr was noted however, increase in the patient's blood pressure was reported.With in minutes of successful deployment of the 22mm amplatzer vascular plug ii the device embolized into the left atrium (la) and it was decided to leave the device in the la.Post procedure the patient was transferred into palliative care in the ccu (cardiac care unit).

• 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: 8944491
• Report Number: 2135147-2019-00273
• Device Sequence Number: 11287428
• Product Code: KRD
• UDI-Device Identifier: 00811806010427
• UDI-Public: 00811806010427
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K071125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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: 04/30/2024
• Device Model Number: 9-AVP2-018
• Device Catalogue Number: 9-AVP2-018
• Device Lot Number: 6996646
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 9-AVP2-022, 701807
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention