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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 FVL08080
Device Problems Positioning Failure (1158); Fracture (1260); Misfire (2532); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/31/2017
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 return of the device is pending.The investigation of the reported event is currently underway.The catalog number identified in section 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 vascular stent graft products are identified.Accordingly, this event has been determined to be mdr reportable.(b)(4).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 intended for an aneurysm in the right internal iliac artery with access through a tortuous left brachial artery, the stent graft allegedly partially deployed by 5mm from the tip.Reportedly, multiple attempts were made in an effort to deploy the rest of the stent resulting in an alleged outer catheter fracture.Furthermore, the device was removed from the patient and another stent graft was used to complete the procedure.Patient tolerated the procedure and is in stable condition.
 
Manufacturer Narrative
Manufacturing review: 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.No additional complaint has been reported for this lot number previously.Investigation summary: on the basis of the returned stent graft delivery system, the alleged deployment failure could be confirmed.The stent graft was found partially released and the outer sheath was found to be highly elongated and fractured, which indicated that increased friction affected the delivery system during attempt of stent graft deployment.In addition, the inner catheter was found to be detached which indicated that excessive force was present.The reported application presents an off label use of the device.However, based on the information available and the evaluation of the sample returned, 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 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." regarding the placement site the ifu states: "the safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have not been established." (b)(4).
 
Event Description
It was reported that during a stent graft deployment procedure intended for an aneurysm in the right internal iliac artery with access through a tortuous left brachial artery, the stent graft allegedly partially deployed by 5mm from the tip.Reportedly, multiple attempts were made in an effort to deploy the rest of the stent resulting in an alleged outer catheter fracture.Furthermore, the device was removed from the patient and another stent graft was used to complete the procedure.Patient tolerated the procedure and is in stable condition.
 
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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 Key7061956
MDR Text Key93227375
Report Number9681442-2017-00301
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741145117
UDI-Public(01)00801741145117
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
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 02/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/29/2020
Device Catalogue NumberFVL08080
Device Lot NumberANBP1114
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2017
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 Age73 YR
Patient Weight62
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