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 Hemorrhage/Bleeding (1888); Stenosis (2263)

Event Date 05/29/2019

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.Journal article citation: lv, y., yang, z., he, c., li, k., wang, z., niu, j., ¿ han, g.(2019).Ps-024-early tips with covered stent versus standard treatment for acute variceal bleeding among patients with advanced cirrhosis: a randomised controlled trial.Journal of hepatology, 70(1).Doi: 10.1016/s0618-8278(19)30030-1.

Event Description

It was reported in an article from the journal of the lancet gastroenterology & hepatology titled " early tips with covered stents versus standard treatment for acute variceal bleeding in patients with advanced cirrhosis: a randomised controlled trial " that in a randomised controlled trial of 132 patients end points were compared between early transjugular intrahepatic portosystemic shunts (tips group) and control group (standard treatment group).Six patients underwent tips revision due to rebleeding and remained free from rebleeding thereafter; two patients received medical and endoscopic treatment for the management of rebleeding and required later shunt revision for stent stenosis associated with rebleeding.

• 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: 9276006
• MDR Text Key: 165224293
• Report Number: 9681442-2019-00207
• 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: 11/04/2019

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: 10/08/2019
• Initial Date FDA Received: 11/04/2019
• 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): Required Intervention