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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
Catalog Number FEM12060
Device Problems Fracture (1260); Material Perforation (2205); Misfire (2532); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/21/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.Expiry date: 04/2022.
 
Event Description
It was report during stent placement procedure in the left basilic fistula which is highly calcified, the stent allegedly failed to deploy.The procedure was completed using another device.There was no reported patient injury.
 
Event Description
It was report during stent placement procedure in the left basilic fistula which is highly calcified, the stent allegedly failed to deploy.The procedure was completed using another device.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: the lot history records have been 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 device was returned for evaluation.Based on the investigation of the returned catheter sample it was confirmed that the user could only partially deploy the stent graft.The deployment mechanism was found in used condition, and one stent graft strut was found perforating the outer sheath which made stent graft deployment impossible.Sheath was identified fractured.Potential factors which may have caused or contributed to the reported issue have been considered.Therefore, previous investigations of similar complaints have been reviewed.During evaluation it was found that the stent graft could not be deployed because a stent graft strut was perforating the distal outer sheath of the delivery system.This issue may be associated with difficult anatomic conditions or challenging placement site leading to increased friction and subsequent damage of the outer sheath.Insufficient flushing of the device prior to use may be a contributing factor to increased friction.In this case the lesion was pretty calcified as it was reported.It is not known if the device was flushed prior to use or not.Based on the information available and the evaluation of the sample returned, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential risk.The instructions for use states: 'if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device.' instructions for use state 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.' moreover.Furthermore, the instructions for use states: 'prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline (¿).Flushing these lumens will also facilitate stent graft deployment.' h10: b3, d4 (expiry date: 04/2022), 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.
 
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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
MDR Report Key11398538
MDR Text Key234259001
Report Number2020394-2021-00404
Device Sequence Number1
Product Code PFV
Combination Product (y/n)N
PMA/PMN Number
P130029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFEM12060
Device Lot NumberANDR1785
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2021
Date Manufacturer Received03/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age28 YR
Patient Weight86
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