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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 FVL14120
Device Problems Positioning Failure (1158); Misfire (2532)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/27/2017
Event Type  malfunction  
Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that during a stent graft deployment procedure for an aneurysm in the tortuous right common iliac with access through the right femoral artery, the device allegedly failed to deploy even after applying excessive force.Another device was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
A manufacturing review was performed.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: based on the investigation of the returned sample it was confirmed that the deployment mechanism could only partially deploy the stent graft.During evaluation testing the partially released stent graft could not be further deployed because a high deployment force was encountered.The reported application presents an off label use of the device.Potential factors which may have caused or contributed to the reported issue have been considered.However, a definite root cause for the reported event could not be determined.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 and the patient anatomy 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.', and '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.' regarding the indication the ifu states: 'the safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have not been established.' the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that during a stent graft deployment procedure for an aneurysm in the tortuous right common iliac with access through the right femoral artery, the device allegedly failed to deploy even after applying excessive force.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
Manufacturer (Section G)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM   76227
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key7099935
MDR Text Key94284372
Report Number9681442-2017-00306
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741145377
UDI-Public(01)00801741145377
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
P130029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 01/30/2018
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 Expiration Date01/20/2020
Device Catalogue NumberFVL14120
Device Lot NumberANBN2487
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/13/2017
Initial Date FDA Received12/08/2017
Supplement Dates Manufacturer Received01/18/2018
Supplement Dates FDA Received01/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/30/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age81 YR
Patient Weight77
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