Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS VASCULAR STENT GRAFT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS VASCULAR STENT GRAFT Back to Search Results
Catalog Number FVL12040
Device Problems Break (1069); Misfire (2532); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/19/2024
Event Type  malfunction  
Event Description
It was reported that during a stent graft placement procedure in the left subclavian artery opening during supra-architectural windowing via the right femoral artery, it was allegedly unable to retract the outer sheath to complete the release without completing the pre-release preparations adequately and without any inappropriate manipulation, and stent implantation was ultimately abandoned after several unsuccessful attempts.It was further reported that after the failure of the first release, there was allegedly a slight notch found at the head end of the conveyor system.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: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 08/2026).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.
 
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 delivery system was not returned for evaluation.Provided photos show the delivery system of the complaint sample with the stent graft still loaded in the catheter and the stent catheter is kinked in the area between the proximal end of the stent and the pusher.The tip of the delivery system is occluded with coagulated blood such that visibility is not clear and partial deployment can't be seen which leads to inconclusive results.It was reported that a 10f introducer / 0.035" guidewire were used for access, there was no serious bending of the tracking and no calcification, the lesion was not pre-expanded, a notch was found at the distal end of the device and the device was flushed before use.Based on provided photos and as the sample was not returned for evaluation, the investigation is closed with confirmed results for material deformation.A definite root cause for the reported event could not be determined.The intended use of this device in the left subclavian artery represents an off-label use.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Regarding anatomy the instructions for use states "if excessive force is felt during stent graft deployment, do not force the delivery system.Remove the delivery system and replace with a new unit".Regarding preparation of the device 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.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.Visually inspect the fluency plus vascular stent graft to verify that the device has not been damaged due to shipping or improper storage.Do not use a damaged device.The fluency plus vascular stent graft is indicated for the treatment of atherosclerotic lesions in the iliac arteries.The intended use of this device in the subclavian artery represents an off-label use.H10: d4 (expiration date: 08/2026).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 a stent graft placement procedure in the left subclavian artery opening via the right femoral artery, it was allegedly unable to retract the outer sheath to complete the release without completing the pre-release preparations adequately and without any inappropriate manipulation, and stent implantation was ultimately abandoned after several unsuccessful attempts.It was further reported that after the failure of the first release, there was allegedly a slight notch found at the head end of the conveyor system.There was no reported patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18923656
MDR Text Key337898917
Report Number9681442-2024-00049
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741145278
UDI-Public(01)00801741145278
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 04/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFVL12040
Device Lot NumberANHV1061
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/18/2024
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
-
-