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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 FEM07060
Device Problems Difficult or Delayed Positioning (1157); Misfire (2532)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/04/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history record could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.
 
Event Description
It was reported that during stent placement procedure, the stent allegedly deployed partially.It was further reported that loosing and tightening the touhy, the stent finally deployed.There was no reported patient injury.
 
Event Description
It was reported that during stent placement procedure, the stent allegedly deployed partially.It was further reported that loosing and tightening the touhy, the stent finally deployed.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: the lot history record of this lot was 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 of the returned delivery system, stent was found missing as it was reported.Elongation of the outer sheath was identified which indicates the amount of force that was applied although it will result to inconclusive result for the reported failure code misfire.In this case, the system reportedly was flushed, and the vessel was not tortuous and/ or calcified; the lesion was pre dilated, and the system worked after losing and tightening the tuohy borst valve.There was no difficulty advancing and retracting the system.Based on information available and returned device, the investigation is confirmed for difficulty deploying the stent.A definite root cause for the reported issue can not be determined.Labeling review: in reviewing the relevant labeling 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.', 'prior to loading the delivery system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment.', the 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.', and 'when the stent graft is ready for deployment, open the tuohy-borst valve by turning it counter clockwise (¿)'.H10: d4(expiry date: 01/2022),g3 h11: d4(medical device lot no),h6(method, result and 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 Key11397325
MDR Text Key234208954
Report Number2020394-2021-00394
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 06/15/2021
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 NumberFEM07060
Device Lot NumberANDZ2164
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2021
Date Manufacturer Received06/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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