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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 FVL12060
Device Problems Material Invagination (1336); Premature Activation (1484); Retraction Problem (1536); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/11/2018
Event Type  malfunction  
Manufacturer Narrative
Manufacturing review: based on the information available 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: the physical sample was not returned, and images were not provided.The alleged issue could not be re produced which led to an inconclusive evaluation result.Based on the information available, and because the sample was not returned a definite root cause for the reported event could not be determined.Labeling review: 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.' the ifu further states: 'if resistance is felt in passing the introducer sheath, the flexible deployment system should be removed together with the introducer sheath.After withdrawing the deployment system, visually confirm that the complete system has been removed.(see figure 11) inner catheter with flared distal end (b) outer sheath with radiopaque marker band (c)'.A labeling symbol on the packaging indicates that the system is for use with a 10f introducer sheath.(b)(4).
 
Event Description
It was reported that during a stent graft deployment procedure, there was alleged difficulty advancing the delivery system through the 10f introducer sheath, therefore the healthcare professional (hcp) retracted the delivery system and experienced difficulty in doing so.It was further reported that upon retraction, the stent graft prematurely deployed and the tip allegedly detached.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: based on the information available 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: based on the investigation of the returned catheter sample tip invagination could be confirmed.However, an alleged detachment, breakage of the tip or a premature stent graft deployment could be unconfirmed; the stent graft was found fully loaded and the tip was not detached or broken.The safety clip was found correctly attached which indicated that the user did not initiate stent graft deployment, as reported.During evaluation the system could be successfully flushed, and a system compatible 0.035" guidewire could be easily inserted and fully advanced; the system could be successfully inserted into a system compatible 10f introducer sheath.It was concluded that the tip invaginated during the unsuccessful attempt to insert the system.An indication for a manufacturing related issue could not be found.Based on the information available, and the investigation performed a definite root cause for the reported event could not be determined.Labeling review: 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.' the ifu further states: 'if resistance is felt in passing the introducer sheath, the flexible deployment system should be removed together with the introducer sheath.After withdrawing the deployment system, visually confirm that the complete system has been removed.(see figure 11) inner catheter with flared distal end (b) outer sheath with radiopaque marker band (c)'.A labeling symbol on the packaging indicates that the system is for use with a 10f introducer sheath.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.
 
Event Description
It was reported that during a stent graft deployment procedure, there was alleged difficulty advancing the delivery system through the 10f introducer sheath, therefore the healthcare professional (hcp) retracted the delivery system and experienced difficulty in doing so.It was further reported that upon retraction, the stent graft prematurely deployed and the tip allegedly detached.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 Key8118523
MDR Text Key128873684
Report Number9681442-2018-00208
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741145285
UDI-Public(01)00801741145285
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 03/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFVL12060
Device Lot NumberANAS0528
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2019
Date Manufacturer Received03/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age69 YR
Patient Weight85
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