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

Model Number FEM08040

Device Problems Positioning Failure (1158); Fracture (1260)

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

Event Date 11/22/2021

Event Type  malfunction  

Event Description

It was reported that during a stent graft placement procedure, the outer catheter allegedly fractured and stent graft could not be deployed.The procedure was completed by 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 will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date: 04/2024.

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 physical device was not returned and no images were provided for evaluation.The returned sample analysis could not be performed.In this case, an appropriate guidewire was used, the system was entered bareback.Therefore, the investigation is inconclusive for the reported issue.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.Regarding the preparation of the device the instructions for use states 'flush the stent graft lumen with sterile saline by using a small volume syringe (¿) close the stopcock when flushing is complete and remove the syringe from the luer port'.Regarding the precautions prior and during deployment 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¿, ¿higher deployment force may be encountered (¿) in tortuous anatomy¿ and '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.¿ the instructions for use states regarding the accessories 'the use of an appropriately sized introducer sheath is recommended; prepare a stiff 0.035" guidewire per its instructions for use and advance the guidewire under fluoroscopy to the target location' the packaging pictograms indicate an introducer size of 9f and a 0.035" guidewire.H10: b5, d4 (expiry date: 04/2024), g3.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.H3 other text : device not returned.

Event Description

It was reported that during a stent graft placement procedure after a/v graft thrombectomy, the outer catheter would not slide and allegedly fractured; the stent graft failed to deploy.The procedure was completed by 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13278712
• MDR Text Key: 283959118
• Report Number: 2020394-2022-00012
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008486
• UDI-Public: (01)04049519008486
• 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: 02/09/2022

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
• Device Operator: Health Professional
• Device Model Number: FEM08040
• Device Catalogue Number: FEM08040
• Device Lot Number: ANFR1279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/18/2022
• Supplement Dates Manufacturer Received: 02/09/2022
• Supplement Dates FDA Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 63 KG