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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 FVL06060
Device Problems Fracture (1260); Misfire (2532)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/13/2023
Event Type  malfunction  
Event Description
It was reported that during a stent graft placement procedure through right femoral artery, the outer sheath allegedly could not be withdrawn and opened normally.It was further reported that the stent graft allegedly partially released.The procedure was completed using another device.There was no reported patient injury.
 
Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 04/2024).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.
 
Event Description
It was reported that during a stent graft placement procedure through right femoral artery, the outer sheath allegedly could not be withdrawn and opened normally.It was further reported that the stent graft was allegedly partially released.Furthermore, as the part of the stent was released, there was friction which made it difficult to remove the system from the introducer sheath.The procedure was completed using another device.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 stent graft delivery system was returned for evaluation and the stent graft was found partially deployed.Also, photos were provided which show the stent graft partially deployed.The sheath was elongated and fractured which leads to confirmed results for partial stent graft release and sheath fracture.It was reported that an 8f introducer / 0.035" guidewire were used for access, the tracking vessel was neither tortuous nor calcified, the proximal end of the stent graft placed in a straight section of the lumen prior to stent graft deployment, the device was flushed and the lesion was pre-dilated.Based on analysis of the provided photos and evaluation of the returned sample, the investigation is closed with confirmed results for partial deployment and sheath fracture.Based on information available a definite root cause for the reported issue 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 tortuous anatomy the instructions for use 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".Regarding preparation of the device the instructions for use states: the instructions for use states: "prior to loading the delivery system over a guide wire, both ports must be flushed with sterile saline to eliminate any air bubbles that may be trapped in the inner catheter lumen and/or the stent graft lumen.Flushing these lumens will also facilitate stent graft deployment.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 8f and a 0.035" guidewire.Predilatation of the stenosis may be performed prior to stent graft deployment at the discretion of the physician'.H10: (expiry date: 04/2024).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.
 
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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 Key18281915
MDR Text Key329908768
Report Number9681442-2023-00390
Device Sequence Number1
Product Code PFV
Combination Product (y/n)N
Reporter Country CodeCH
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFVL06060
Device Lot NumberANFR2442
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/20/2023
Was Device Evaluated by Manufacturer? Yes
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 Age70 YR
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