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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 FVL10100
Device Problems Positioning Failure (1158); Fracture (1260); Material Invagination (1336)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2018
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 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.(b)(4).
 
Event Description
It was reported that during a stent graft deployment procedure through the right brachial artery into a calcified internal iliac artery, the stent graft allegedly failed to deploy.It was further reported that upon increased force in attempting to deploy the stent graft, the outer sheath catheter allegedly fractured.Another stent graft was used to complete the procedure.There was no reported patient injury.
 
Event Description
It was reported that during a stent graft deployment procedure through the right brachial artery into a calcified internal iliac artery, the stent graft allegedly failed to deploy.It was further reported that upon increased force in attempting to deploy the stent graft, the outer sheath catheter allegedly fractured.Another stent graft was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: 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.Investigation summary: based on the investigation of the returned catheter sample a partial stent graft deployment and sheath fracture could be confirmed.The outer sheath was found elongated and fractured which indicated that a high release force was present when the fracture occurred.Outer catheter damage was visible which indicated that the outer catheter may have been weakened before fracture, but it was not known when this damage was caused.An indication for a manufacturing related issue could not be found.Based on the information available, 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.' in regards to preparation/ access site the ifu states: 'a super stiff guide wire (0.035 in) is advanced from a femoral artery puncture site.(eval code & desc- results 1 and conclusion1).
 
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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 Key8085454
MDR Text Key127858391
Report Number9681442-2018-00202
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741145247
UDI-Public(01)00801741145247
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 12/05/2018
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 Date05/31/2020
Device Catalogue NumberFVL10100
Device Lot NumberANBS3448
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2018
Initial Date Manufacturer Received 10/23/2018
Initial Date FDA Received11/19/2018
Supplement Dates Manufacturer Received11/23/2018
Supplement Dates FDA Received12/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age64 YR
Patient Weight100
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