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

Model Number FEM14040

Device Problems Material Perforation (2205); Misfire (2532)

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

Event Date 10/05/2021

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure in left arm fistula, the stent would not unsheathe for deployment.It was further reported that the radiopaque markers were 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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 08/2023).

Manufacturer Narrative

Manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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.Investigation summary: the sample was returned for evaluation.Based on the sample evaluation, the stent graft was partially deployed by about 2 mm.One of the stent struts perforated the outer sheath.Based on returned sample analysis, the investigation of the reported partial deployment is confirmed.Material perforation as reported was equally confirmed.It is reported that the system was flushed, device compatible accessories were used.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 stent deployment, the instructions for use states "if resistance is encountered removing the delivery system, it is recommended to remove the delivery system, introducer and guidewire as a single unit".Regarding preparation of the device the instructions for use states that "prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline to eliminate any air bubbles that may be trapped in the inner catheter lumen and/or the stent graft lumen.Flushing these lumens will also facilitate stent graft deployment".With regards to directions for use, 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".Regarding the placement site, instructions for use states: ' vascular stent graft.For use in the iliac and femoral arteries'.Based on reported information, the intended placement site for this stent was the venous system which represents off-label use.D4 (expiry date: 08/2023).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 in left arm fistula, the stent would not unsheathe for deployment.It was further reported that the radiopaque markers were partially deployed.It was further reported that the stent strut poked through the sheath.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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12889065
• MDR Text Key: 281392018
• Report Number: 2020394-2021-02012
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008684
• UDI-Public: (01)04049519008684
• 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: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FEM14040
• Device Catalogue Number: FEM14040
• Device Lot Number: ANEV1658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• 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 Sex: Male
• Patient Weight: 113 KG