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

Model Number	FEM12120
Medical Device Problem Codes	Misfire (2532); Malposition of Device (2616); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.However, images were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 06/2024).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 : device pending return.
Event or Problem Description
It was reported that during stent placement procedure in the right forearm arteriovenous fistula, the stent was allegedly failed to open completely.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the stent delivery system was returned for evaluation and the stent was completely deployed and not returned since it was placed in the patient.From the provided images, it is clear that the stent didn't cover the intended area which was supposed to be the placement site which leads to confirmed results for malpositioning.It was reported that there was significant angulation at the proximal landing site and the device was flushed, the procedure was sheathless and a 0.035" guidewire was used.It was also mentioned that after manipulation, the stent deployed at a site not beneficial to the patient (malpositioning).Based on the provided information and the evaluation of the returned sample, the investigation is closed with confirmed results for stent malpositioning.A definite root cause for the reported event could not be determined.The placement of this device to treat pseudoaneurysm represent an off-label use.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.The instructions for use state: '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.' 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: "prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location.The use of an appropriately sized introducer sheath is recommended".The packaging pictograms indicate an introducer size of 10f and a 0.035" guidewire.The fluency plus endovascular stent graft is indicated for use in the treatment of in-stent restenosis in the venous outflow of hemodialysis patients dialyzing by either an arteriovenous (av) fistula or av graft and for the treatment of stenosis in the venous outflow of hemodialysis patients dialyzing by an av graft.The safety and effectiveness of the device when placed across an aneurysm or a pseudoaneurysm has not been evaluated.The instructions for use mentions stent graft misplacement as a potential complication of the use of this stent.H10: d4 (expiry date: 06/2024).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 or Problem Description
It was reported that during stent placement procedure in the right forearm arteriovenous fistula, the stent was allegedly failed to open completely.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the initial mdr was inadvertently submitted with a g3 date of 04/18/23.The correct g3 date is 04/17/23.H10: manufacturing review: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the stent delivery system was returned for evaluation and the stent was completely deployed and not returned since it was placed in the patient.From the provided images, it is clear that the stent didn't cover the intended area which was supposed to be the placement site which leads to confirmed results for malpositioning.It was reported that there was significant angulation at the proximal landing site and the device was flushed, the procedure was sheathless and a 0.035" guidewire was used.It was also mentioned that after manipulation, the stent deployed at a site not beneficial to the patient (malpositioning).Based on the provided information and the evaluation of the returned sample, the investigation is closed with confirmed results for stent malpositioning.A definite root cause for the reported event could not be determined.The placement of this device to treat pseudoaneurysm represent an off-label use.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.The instructions for use state: '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.' 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: "prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location.The use of an appropriately sized introducer sheath is recommended".The packaging pictograms indicate an introducer size of 10f and a 0.035" guidewire.The fluency plus endovascular stent graft is indicated for use in the treatment of in-stent restenosis in the venous outflow of hemodialysis patients dialyzing by either an arteriovenous (av) fistula or av graft and for the treatment of stenosis in the venous outflow of hemodialysis patients dialyzing by an av graft.The safety and effectiveness of the device when placed across an aneurysm or a pseudoaneurysm has not been evaluated.The instructions for use mentions stent graft misplacement as a potential complication of the use of this stent.H10: d4 (expiry date: 06/2024), g3 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 or Problem Description
It was reported that during stent placement procedure in the right forearm arteriovenous fistula, the stent was allegedly failed to open completely.There was no reported patient injury.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Common Device Name: 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16930593
• Report Number: 2020394-2023-00335
• Device Sequence Number: 15163892
• Product Code: PFV
• UDI-Device Identifier: 04049519008677
• UDI-Public: (01)04049519008677
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P130029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2023

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
• Operator of Device: Health Professional
• Device Model Number: FEM12120
• Device Catalogue Number: FEM12120
• Device Lot Number: ANFT0396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 05/25/2023; 06/12/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 06/01/2023; 06/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female