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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS VASCULAR STENT GRAFT
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS VASCULAR STENT GRAFT Back to Search Results
Catalog Number FVL12080
Device Problems Misfire (2532); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/21/2019
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will 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.The catalog number identified has not been cleared in the us, but is similar to the fluency plus endovascular stent graft products that are cleared in the us.
 
Event Description
It was reported that during a stent graft deployment procedure to treat a thrombotic left iliac vein through a retrograde right common femoral approach, the stent graft allegedly partially deployed approximately 1cm.Therefore, another device was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: based on the information available and the investigation performed, there is no indication that the product failed to meet its specification prior to shipment.The lot records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.Investigation summary: a stent graft delivery system was returned.Based on the evaluation of the returned sample the reported partial deployment could be confirmed.The outer sheath was found elongated which indicated that high release force was present during evaluation which led to a partially deployed stent graft.A manufacturing related issue could not be identified.Based on the information available, a definite root cause for the reported event could not be determined.The reported application presents an off label use of the device.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding preparation of the device the ifu states: "prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline.Flushing these lumens will also facilitate stent graft deployment." regarding the anatomy of the placement site, the ifu states: "prior to stent graft deployment, ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy." the reported use of the delivery system in the iliac vein presents an off label use of the device.Based on the ifu supplied with this product, the fluency plus vascular stent graft system is indicated for use in the iliac and femoral arteries.
 
Event Description
It was reported that during a stent graft deployment procedure to treat a thrombotic left iliac vein through a retrograde right common femoral approach, the stent graft allegedly partially deployed approximately 1cm.Therefore, another device was used to complete the procedure.There was no reported patient injury.
 
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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
MDR Report Key8339948
MDR Text Key136164258
Report Number9681442-2019-00018
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741145292
UDI-Public(01)00801741145292
Combination Product (y/n)N
PMA/PMN Number
P130029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2020
Device Catalogue NumberFVL12080
Device Lot NumberANBZ2748
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2019
Date Manufacturer Received05/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age58 YR
Patient Weight78
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