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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 08/02/2018
Event Type  malfunction  
Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation 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 vascular stent graft deployment procedure to treat the intra-renal abdominal aorta via the left common femoral artery (cfa) access, the stent graft allegedly failed to deploy from the delivery system despite excessive force applied in an effort to attempt deploy the stent graft.There was no reported difficulty in retracting the delivery system from the patient.Reportedly, the stent graft delivery system was exchanged for another in order to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: the lot history 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.No additional complaint has been previously reported for this lot number.Investigation summary: the stent graft delivery system was returned for evaluation.Based on the evaluation of the returned sample, it was confirmed that the stent could only be partially deployed.The condition of the sample, in particular elongation of the outer sheath indicates that increased deployment forces occurred during the attempt to deploy the stent graft.This may have been caused by increased friction.An indication for a manufacturing related cause could not be found.The reported application represents an off label use of the device.Therefore, the complaint is confirmed, however, based on the information available and the evaluation of the sample a definite root cause for the reported event could not be determined.Labeling review: in reviewing the currently available 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: "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 application represents an off label use of the device.Based on the ifu supplied with this product the device is indicated for use in the iliac and femoral arteries.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 vascular stent graft deployment procedure to treat the intra-renal abdominal aorta via the left common femoral artery (cfa) access, the stent graft allegedly failed to deploy from the delivery system despite excessive force applied in an effort to attempt deploy the stent graft.There was no reported difficulty in retracting the delivery system from the patient.Reportedly, the stent graft delivery system was exchanged for another in order 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 Key7858138
MDR Text Key119661908
Report Number9681442-2018-00165
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741145377
UDI-Public(01)00801741145377
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 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2021
Device Catalogue NumberFVL14120
Device Lot NumberANCQ4622
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2018
Date Manufacturer Received10/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age74 YR
Patient Weight75
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