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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; VASCULA STENT GRAFT
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS VASCULAR STENT GRAFT; VASCULA STENT GRAFT Back to Search Results
Catalog Number FVL10040
Device Problems Positioning Failure (1158); Fracture (1260); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2021
Event Type  malfunction  
Event Description
It was reported that during a stent placement procedure through the right femoral artery via the internal iliac artery and once the device reached the desired position, resistance was felt upon deployment and the stent failed to deploy.It was further reported that delivery system allegedly had difficulty on removal.The procedure was completed using another device.There was no reported patient injury.
 
Manufacturer Narrative
The catalog number identified 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.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 04/2022).
 
Manufacturer Narrative
The catalog number identified 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.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 04/2022).
 
Event Description
It was reported that during a stent placement procedure through the right femoral artery via the internal iliac artery and once the device reached the desired position, resistance was felt upon deployment and the stent failed to deploy.It was further reported that delivery system allegedly had difficulty on removal.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: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.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 returned to the manufacturer for evaluation.Based on the investigation performed in the laboratory, the outer sheath was found fractured and the stent graft completely deployed.Therefore the fracture of the outer sheath is confirmed as the main issue to the reported event; however, the reported failure to deploy could not be confirmed.In this case, the vessel was reported to be mild calcified, which could have increased the release forces; however, there is no sufficient evidence to address the tortuous anatomy as the main issue to the reported event.The system was appropriately flushed and an 8f introducer sheath was reported to be used.Additionally, it is known that the system was straightened prior to deployment, but not if the proximal end of the stent graft was placed in a straight section of the lumen prior to deployment.A definitive root cause could not be determined based upon the available information.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 9f and a 0.035" guidewire.H10: d4 (expiry date: 04/2022), g3.H11: h6 (result, conclusion).H11: section a through f ¿ the information provide 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 : see h10.
 
Event Description
It was reported that during a stent placement procedure through the right femoral artery via the internal iliac artery and once the device reached the desired position, resistance was felt upon deployment and the stent failed to deploy.It was further reported that delivery system allegedly had difficulty on removal.The procedure was completed using another device.There was no reported patient injury.
 
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Brand Name
FLUENCY PLUS VASCULAR STENT GRAFT
Type of Device
VASCULA 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
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key13379658
MDR Text Key286149689
Report Number9681442-2022-00003
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741145216
UDI-Public(01)00801741145216
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 01/31/2022
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 Catalogue NumberFVL10040
Device Lot NumberANDR3726
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/03/2022
Initial Date FDA Received01/28/2022
Supplement Dates Manufacturer Received01/31/2022
Supplement Dates FDA Received02/03/2022
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 Age67 YR
Patient SexMale
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