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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 FVL12120
Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/27/2023
Event Type  malfunction  
Manufacturer Narrative
The catalog number identified in section d4 has not been cleared in the us but is similar to the fluency plus endovascular stent graft that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft are identified in d2 and g4.As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 09/2024).The information provided by bd represents all 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 bd.Device not returned.
 
Event Description
It was reported that during an attempt to place two stent grafts in the same procedure, the stent graft was allegedly difficult to deploy, even after it was properly flushed.It was further reported that the y-adapter got disconnected from the delivery catheter.Reportedly, the stent graft was deployed after much effort but misplaced due to proximal migration.There was no reported patient injury.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the fluency plus endovascular stent graft that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft are identified in d2 and g4.H10: manufacturing review: based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were 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.Investigation summary: the sample was not returned for evaluation and photos were not provided which leads to inconclusive results.It was reported that the device was flushed, and the delivery system was straightened and placed in the straight section of the lumen during deployment attempts.Two devices were involved; a hydrophil and teflon guide wire/7f and 10f introducer sheaths were used, but it is not known which one was used for this procedure.Based on the provided information and as the sample was not returned, the investigation is closed with inconclusive results.The intended placement of the device to treat aortic aneurysm represent off-label use.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Regarding preparation of the device the instructions for use state 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 instructions for use 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 accessories the instructions for use states: "a super stiff guide wire (0.035 in.) is advanced from a femoral artery puncture site.Use an introducer sheath for the implant procedure"; the packaging pictograms indicate an introducer size of 10f and a 0.035" guidewire.Regarding indications for use, the instructions for use states that the fluency plus vascular stent is "for use in the iliac and femoral arteries".The safety and effectiveness of the device for use in the treatment of aneurysms and pseudoaneurysms have not been established.H10: (expiration date: 09/2024).H11: section a through f ¿ the information provided by bd represents all 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 bd.H3 other text: device not returned.
 
Event Description
It was reported that during an attempt to place two stent grafts in the same procedure, the stent graft was allegedly difficult to deploy, even after it was properly flushed.It was further reported that the y-adapter got disconnected from the delivery catheter.Reportedly, the stent graft was deployed after much effort but misplaced due to proximal migration.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
wachhausstr. 6
karlsruhe 76227
GM  76227
Manufacturer (Section G)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstr. 6
karlsruhe 76227
GM   76227
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key17002124
MDR Text Key316054791
Report Number9681442-2023-00201
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741145315
UDI-Public(01)00801741145315
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P130029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFVL12120
Device Lot NumberANFW1304
Was Device Available for Evaluation? No
Date Manufacturer Received05/31/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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