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

Catalog Number UNK FLUENCYPLUS VASC STNT GRFT

Device Problem Obstruction of Flow (2423)

Patient Problems Encephalopathy (1833); Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 07/23/2018

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: yu, j., wang, x., jiang, m., ma, h., zhou, z., yang, l., & li, x.(2018).Comparison of transjugular intrahepatic portosystemic shunt (tips) alone and combined with embolisation for the management of cardiofundal varices: a retrospective study.European radiology, 29(2), 699¿706.Doi: 10.1007/s00330-018-5645-2.[(b)(4)].

Event Description

It was reported in an article from the journal of european radiology titled " comparison of transjugular intrahepatic portosystemic shunt (tips) alone and combined with embolisation for the management of cardiofundal varices: a retrospective study " that in a retrospective study of 82 patients efficacy of tips with and without adjunctive embolisation was assessed.Stent dysfunction occurred in 9 patients, which was defined as stenosis or occlusion confirmed through contrast-enhanced computed tomography; 6 patients experienced gastric varices rebleeding, however, shunt patency was restored with tips revision in seven patients.During the follow-up, 28 patients experienced overt hepatic encephalopathy and 13 patients suffered a recurrent haemorrhages from the varices rupture.The status of the patients was not provided.

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASULAR 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: 9321869
• MDR Text Key: 166362840
• Report Number: 9681442-2019-00217
• 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: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• 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
• Date Manufacturer Received: 10/21/2019
• 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