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

Catalog Number UNK FLUENCYPLUS VASC STNT GRFT

Device Problem Obstruction of Flow (2423)

Patient Problems Embolism (1829); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 02/27/2019

Event Type  Injury  

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)(4).Journal article citation: luo, x., zhao, m., wang, x., jiang, m., yu, j., li, x., & yang, l.(2019).Long-term patency and clinical outcome of the transjugular intrahepatic portosystemic shunt using the expanded polytetrafluoroethylene stent-graft.Plos one, 14(2).Doi: 10.1371/journal.Pone.0212658.[(b)(4)].

Event Description

It was reported in an article in the journal of plos one titled " long-term patency and clinical outcome of the transjugular intrahepatic portosystemic shunt using the expanded polytetrafluoroethylene stent-graft " that in a retrospective study of 495 patients who underwent transjugular intrahepatic portosystemic shunt (tips) with the fluency stent-grafts between december 2011 and june 2015, tips-related complications occurred in 67 patients during the index hospital stay.The patients responded well to the conservative treatment for post-tips infection (60), pulmonary embolization (1), intra-abdominal bleeding (4) and bile duct injury with biliary hemorrhage (1), stent revision was required for the patients with shunt occlusion (18) and stenosis (19), however, the patent status was not provided for hepatic encephalopathy (151) and variceal rebleeding (43).

• 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: 9256557
• MDR Text Key: 164332578
• Report Number: 9681442-2019-00204
• 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: 10/30/2019

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?: 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
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/30/2019
• 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