MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS VASCULAR STENT GRAFT

Catalog Number UNK FLUENCYPLUS VASC STNT GRFT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Encephalopathy (1833); Hepatitis (1897); Ascites (2596)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(b)(6).Journal article citation: zuo, l., chen, h., wang, q., he, c., yin, z., tie, j., ¿ han, g.(2017).Early recurrent overt hepatic encephalopathy is associated with poor survival in patients with cirrhosis after transjugular intrahepatic portosystemic shunt.Journal of hepatology, 66(1).Doi: 10.1016/s0168-8278(17)31087-5.

Event Description

It was reported in an article from the journal of vascular interventional radiology titled " early-recurrent overt hepatic encephalopathy is associated with reduced survival in cirrhotic patients after transjugular intrahepatic portosystemic shunt creation " that during follow-up, 115 patients experienced overt hepatic encephalopathy (ohe).Patients with severe ohe were admitted to the intensive care unit and administered empirical he treatment with lactulose and low-protein diet.Refractory ohe required endovascular treatment; seven patients required shunt reduction, one patient required shunt occlusion and four patients required embolization of the collateral vein, however, one patient did not respond to embolization of collateral vein underwent shunt occlusion with improved of ohe.Ohe improved in all twelve patients, who required an additional intervention.

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9316932
• MDR Text Key: 179109709
• Report Number: 9681442-2019-00214
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK FLUENCYPLUS VASC STNT GRFT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention