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

Model Number	9-AVP2-018
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The article, ¿hemodialysis-related portal-systemic encephalopathy: a rare cause of recurrent encephalopathy among patients on maintenance hemodialysis" was reviewed.The research article presents a case study of a 50 years old male with history of diabetes mellitus (dm) with microvascular complications, was initiated on hemodialysis through right ijv cuffed catheter following irreversible acute on chronic kidney disease due to superadded infection-related gn¿ on underlying advanced diabetic nephropathy.He had low c3 levels and kidney biopsy had shown diffuse proliferative glomerulonephritis with background diabetic nodular glomerulosclerosis, 5 of 13 glomeruli showed cellular crescents.The renal function progressively deteriorated despite trial of steroids.His past history was significant for an episode of acute pancreatitis, acute coronary syndrome on medical management and regular alcohol consumption.Two months into hd he developed acute onset altered mental status.On examination, he had gait instability and flaps.His serum ammonia level was elevated (67 mmol/l) despite acceptable urea reduction rates on hemodialysis.Ultrasound abdomen showed fatty liver and upper gi endoscopy showed no varices.Liver stiffness measurement done using echosens fibroscan 402 showed a medium stiffness value of 7.5 kpa.In the absence of advanced cirrhosis and lack of clinically significant portal hypertension a contrast ct of abdomen was done to look for any abnormal portosystemic communication.A tortuous and prominent collateral vein from the portal vein was seen draining to the left renal vein.Shunt embolism by an 18 mm amplatzer vascular plug (avrii) was done on october- 2019.Follow up ct showed complete occlusion of collaterals.He was put on oral anticoagulation in view of thrombosis of common iliac and right external iliac veins after procedure.Post-procedure, patient is undergoing thrice-weekly hemodialysis of 4 hours duration till date with no further incidence of encephalopathy.The article concluded, recurrent encephalopathy can occur in dialysis patients due to symptomatic psvs and hrpse should be considered even in non-cirrhotic cases for early detection and effective management.The primary and correspondence author of the article is, feroz aziz, md, department of nephrology, aster mims hospital, nh 66, calicut, road, changuvetty, kerala 676501, india.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
As reported in a research article, a patient with recurrent hemodialysis treatment underwent a shunt embolism by an 18 mm amplatzer vascular plug ii.An event of thrombosis was reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review, and no device or additional patient information was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.B3: date is estimated.H6: clinical code 4582 was removed and code 4440 was added.

• Brand Name: AMPLATZER VASCULAR PLUG II
• 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: 14838348
• Report Number: 2135147-2022-00448
• Device Sequence Number: 11354528
• Product Code: KRD
• UDI-Device Identifier: 00811806010427
• UDI-Public: 00811806010427
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K071699
• 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,Followup
• Report Date (Section B): 07/19/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-AVP2-018
• Device Catalogue Number: 9-AVP2-018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 07/19/2022
• 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: 50 YR
• Patient Sex: Male