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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 FEM12040
Device Problems Material Invagination (1336); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2018
Event Type  malfunction  
Manufacturer Narrative
Medical images and photos were provided to the manufacturer and are currently under review.The lot number of the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.The information provided by bard represents all of 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 bard.
 
Event Description
It was reported that during a stent graft placement of the right upper arm to treat a previously stenosed bare metal stent, the stent graft system allegedly could not advance through the bare metal stent.A sheath was not used for the stent graft placement.The delivery system was removed without issue.The procedure was completed with another stent graft of smaller size.There was no reported patient injury.
 
Event Description
It was reported that during a stent graft placement of the right upper arm to treat a previously stenosed bare metal stent, the stent graft system allegedly could not advance through the bare metal stent.A sheath was not used for the stent graft placement.The delivery system was removed without issue.The procedure was completed with another stent graft of smaller size.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: based on the information available and the investigation performed, there is no indication that the product failed to meet its specification prior to shipment.The lot 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.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.Investigation summary: based on the evaluation of the returned sample and provided photos/ x-rays the reported positioning issue could not be confirmed.However, the tip of the catheter was found to be invaginated.However, a device compatible guide wire could be advanced through the entire system.Based on the returned sample it could not be determined what caused the invagination of the inner catheter.A manufacturing related cause could not be identified.Therefore, based on sample evaluation a deformation of the distal tip of the delivery system was confirmed.However, a definite root cause could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding, potential damages, the ifu states: "examine the packaging and endovascular system to determine if there is any damage, defects or if the sterile barrier is compromised.Do not use the device if any of these conditions are observed." furthermore, the ifu states regarding the use of accessories: "materials required for the fluency® plus endovascular stent graft procedure:.Introducer sheath with appropriate inner diameter.".
 
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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 Key7567478
MDR Text Key110032309
Report Number2020394-2018-00800
Device Sequence Number1
Product Code PFV
UDI-Device Identifier04049519008639
UDI-Public(01)04049519008639
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 07/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/26/2020
Device Model NumberFEM12040
Device Catalogue NumberFEM12040
Device Lot NumberANBX2693
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2018
Date Manufacturer Received07/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age35 YR
Patient Weight95
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