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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY VASCULAR STENT GRAFT
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY VASCULAR STENT GRAFT Back to Search Results
Catalog Number FVL06060
Device Problem Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
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 was 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 post dilation of the vessel, the stent delivery system allegedly would not advance through an angle to the lesion site.Reportedly, the health care provider removed the stent graft delivery system and no further treatment was provided.There was no reported patient injury.
 
Event Description
It was reported that post dilation of the vessel, the stent delivery system allegedly would not advance through an angle to the lesion site.Reportedly, the health care provider removed the stent graft delivery system and no further treatment was provided.There was no reported patient injury.
 
Manufacturer Narrative
The catalog number has not been cleared in the us, but is similar to the fluency endovascular stent graft products that are cleared in the us.Manufacturing review: 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.Investigation summary: based on the investigation of the returned catheter sample the alleged failure to advance the system to the lesion site could not be confirmed.During evaluation, the deployment mechanism was found in unused and good condition.Any kind of damage on tip or outer system surface indicating unsuccessful tracking could not be identified.Images have not been provided.The investigation is inconclusive.An indication for a process related issue could not be found.Based on the information available and the evaluation performed the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: based on the lot number provided the following version of the instructions for use (ifu) is currently valid: b05663 rev.4/11-14 (16).In reviewing the relevant labeling for this product it was found that the instructions for use (ifu) sufficiently address the potential factors.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.Use an introducer sheath for the implant procedure.' the ifu further states: 'prior to stent graft deployment in tortuous anatomy, 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.'.
 
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Brand Name
FLUENCY 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 Key7520564
MDR Text Key108493079
Report Number9681442-2018-00062
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741144967
UDI-Public(01)00801741144967
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 07/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2020
Device Catalogue NumberFVL06060
Device Lot NumberANBU2020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2018
Date Manufacturer Received06/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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