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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS ENDOVASCULAR STENT GRAFT

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BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS ENDOVASCULAR STENT GRAFT Back to Search Results
Model Number FEM10060
Device Problems Positioning Failure (1158); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2021
Event Type  malfunction  
Event Description
It was reported that during a stent placement procedure, the device allegedly failed to deploy.There was no reported patient injury.
 
Manufacturer Narrative
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 for evaluation.Based on the investigation performed in the laboratory, it is confirmed that the user could not deploy the stent because the outer sheath fractured.Sheath fracture is considered the primary code whereas deployment failure is the subsequent event which leads to confirmed result for sheath fracture.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 the preparation of the device the instructions for use states 'flush the stent graft lumen with sterile saline by using a small volume syringe.A) attach the syringe to the luer port at the back of the endovascular system (.).B) attach the syringe to the luer port on the y-adapter, (.) close the stopcock when flushing is complete and remove the syringe from the luer port'.The instructions for use states regarding the accessories 'the use of an appropriately sized introducer sheath is recommended; prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location' regarding the precautions prior and during deployment the instructions for use states 'prior to stent graft deployment, ensure that the proximal (inflow) stent graft end is positioned in a straight section of the lumen to reduce the risk of higher deployment forces and possible endovascular system failure'.The packaging pictograms indicate an introducer size of 9f and a 0.035" guidewire.(expiry date: 01/2024).
 
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Brand Name
FLUENCY PLUS ENDOVASCULAR STENT GRAFT
Type of Device
ENDOVASCULAR STENT GRAFT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
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 Key12922370
MDR Text Key281651570
Report Number2020394-2021-02030
Device Sequence Number1
Product Code PFV
UDI-Device Identifier04049519008592
UDI-Public(01)04049519008592
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 11/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFEM10060
Device Catalogue NumberFEM10060
Device Lot NumberANFN1078
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/08/2021
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
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