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

Model Number FEM08100

Device Problems Misfire (2532); Malposition of Device (2616); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2023

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure for the left upper arm loop graft repair of enlarging aneurysm.The stent allegedly partially deployed.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, images were provided for review.The investigation of the reported event is currently underway.(expiry date: 08/2025).

Manufacturer Narrative

H10: the fda rn number for the mdr 9681442-2023-00061 was inadvertently submitted as 9681442.The correct fda rn number was 2020394.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 fluency stent graft delivery system was returned for evaluation without stent graft as it reportedly has been deployed in the vessel.The radiopaque sheath marker of the system including tip was found without damage, the inner catheter was protruding the tip and the pusher was out of the catheter indicating regular deployment.The origin of the ring shaped piece inside the vessel was not known which leads to inconclusive evaluation results.Also, photos were provided demonstrating deployment of the stent grafts; a ring shaped piece is visible after deployment of the first fluency that was pinned against the wall with the second fluency.A misplacement cannot be evaluated.Both stent grafts are visibly open and not constricted by the ring shaped piece.The images also demonstrate that the secondly placed fluency landed in a curve that was obstructive and that a third stent was placed to smoothen out this curve.An 8f introducer was used for the 9f system, and a system compatible 0.035" guidewire; the proximal end of the stent graft was placed in a straight section of the lumen before deployment, and the system was straightened.Based on the provided information and the evaluation of the returned sample, the investigation is inconclusive.A definite root cause for the reported event could not be determined.Aneurysm treatment represents 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 (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.' regarding accessories the instructions for use states: 'a super stiff guide wire (0.035 in.) is advanced from a femoral artery puncture site.Use an introducer sheath for the implant procedure'; the packaging pictograms indicate an introducer size of 9f and a 0.035" guidewire.Holding and handling of the system throughout deployment was found sufficiently described.Stent graft misplacement was found mentioned as a potential adverse event.The instructions for use further states: 'the safety and effectiveness of the device when placed across an aneurysm or a pseudoaneurysm has not been evaluated'.H10: d4 (expiry date: 08/2025), g3 h11: b5, h6 (device, method, result, conclusion) h11: section a through f - the information provided by bd 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 bd.

Event Description

It was reported that during a stent placement procedure for the left upper arm loop graft repair of enlarging aneurysm, the stent allegedly detached.It was further reported the device was allegedly malpositioned.The procedure was completed using another device.There was no reported patient injury.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16478590
• MDR Text Key: 310730610
• Report Number: 9681442-2023-00061
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008516
• UDI-Public: (01)04049519008516
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FEM08100
• Device Catalogue Number: FEM08100
• Device Lot Number: ANGV3097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2023
• 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 Number: 1
• Patient Age: 72 YR
• Patient Sex: Male