MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER VASCULAR PLUG; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	9-PLUG-006
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported in a research article, an amplatzer vascular plug migrated one minute after placement and was removed.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or additional information was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
An article from the medical conference abstract magazine for (b)(6) society of congenital interventional cardiology, was reviewed.The research article presents a case of a (b)(6) female who had a non -abbott device implanted in the venous duct at birth and had a history of asplenia, single ventricle, aortic stenosis, coarctation of aorta and complicated by total anomalous pulmonary venous connection (tapvc) in order to postpone the timing of surgery.Bilateral pulmonary arterial banding was performed when the patient was (b)(6).Tapvc repair was conducted at 3 month after the birth.Two week after, norwood surgery and glenn surgery were performed.Residual blood flow was confirmed within the stent.Decreasing saturation of oxygen was observed due to hepatopulmonary syndrome.Prior to fontan surgery, it was decided to embolize the blood flow inside the stent by amplatzer vascular plug (avp)when the patient was (b)(6).A 6mm amplatzer vascular plug was implanted, one minute after, the device migrated into the descending artery was removed by a non -abbott device.The venous duct was surgically semi-sutured and achieved complete closure spontaneously.After that, fontan surgery was undergone and hepatopulmonary syndrome became improved.[ the author and corresponding author of this article is ono, hiroshi, md 157-8535 2-10-1 okura, setagaya-ku, tokyo tel: 03-3416-0181 fax: 03-3416-2222].

• Brand Name: AMPLATZER VASCULAR PLUG
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14493544
• Report Number: 2135147-2022-00311
• Device Sequence Number: 17644490
• Product Code: KRD
• UDI-Device Identifier: 00811806011455
• UDI-Public: 00811806011455
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-PLUG-006
• Device Catalogue Number: 9-PLUG-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 YR
• Patient Sex: Female