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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 FVM14120
Device Problems Positioning Failure (1158); Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
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.The 510 k number and pro code for the fluency plus endovascular stent graft products are identified.(expiry date 08/2021).
 
Event Description
It was reported that during a stent graft deployment procedure in the rip artery, the stent graft allegedly failed to deploy and the outer sheath catheter fractured.There was no reported patient injury.
 
Manufacturer Narrative
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.As part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this particular case the sample was not returned for evaluation.Therefore, the reported problem could not be reproduced and the investigation will be closed with inconclusive result.Based on the information available, a definite root cause for the reported event could not be determined.In reviewing the relevant labeling for this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding preparation of the device the ifu states that '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.'.
 
Event Description
It was reported that during a stent graft deployment procedure in the rip artery, the stent graft allegedly failed to deploy and the outer sheath catheter fractured.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 Key8089554
MDR Text Key128034011
Report Number9681442-2018-00204
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741144974
UDI-Public(01)00801741144974
Combination Product (y/n)N
PMA/PMN Number
P130029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 12/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFVM14120
Device Lot NumberANCT1544
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/26/2018
Initial Date FDA Received11/20/2018
Supplement Dates Manufacturer Received11/30/2018
Supplement Dates FDA Received12/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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