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

Model Number FEM12060

Device Problems Positioning Failure (1158); Misfire (2532)

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

Event Date 02/23/2023

Event Type  malfunction  

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, photos and images were provided for review.The investigation of the reported event is currently underway.Expiry date: 11/2024.Device pending return.

Event Description

It was reported that during a stent graft placement procedure for stenosis in the subclavian vein, the stent allegedly failed to deploy.It was further reported that upon attempting to deploy via pin and pull method, the stent allegedly buckled and would not completely deploy.Reportedly the stent was withdrawn and the procedure was completed using another device.There was no reported patient injury.

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 delivery system was not returned for evaluation.However, photos of the delivery system and x-ray images of the patient¿s anatomy were provided.Based on the photos of the delivery system, partial stent graft deployment is confirmed.Elongation of the outer sheath indicate that increased deployment forces occurred during the attempt to deploy the stent graft.A 7f sheath was used to dilate the access site; but the delivery system was advanced to the target lesion without an introducer sheath.Based on photos provided it is confirmed that the stent graft could not be deployed completely.However, based on the information available, a definite root cause could not be determined.Labeling review: relevant labeling supplied with this product was reviewed.The instruction for use was found to address the potential risks.The instruction for use states: "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 instruction for use states "prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline (.).Flushing these lumens will also facilitate stent graft deployment." in addition, the instruction 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 increased deployment forces and possible endovascular system failure." based on the instruction for use and the package labeling the following accessories should be used: a stiff 0.035" guidewire, an 8g introducer sheath.H10: d4 (expiry date: 11/2024), g3 h11: h6 (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.H3 other text : device not returned.

Event Description

It was reported that during a stent graft placement procedure for stenosis in the subclavian vein, the stent allegedly failed to deploy.It was further reported that upon attempting to deploy via pin and pull method, the stent allegedly buckled and would not completely deploy.Reportedly the stent was withdrawn and 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 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: 16626353
• MDR Text Key: 312436171
• Report Number: 2020394-2023-00203
• Device Sequence Number: 1
• Product Code: PFV
• 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: 03/30/2023

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
• Device Operator: Health Professional
• Device Model Number: FEM12060
• Device Catalogue Number: FEM12060
• Device Lot Number: ANFY0434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 07/05/2023
• Supplement Dates FDA Received: 07/06/2023
• 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: 91 YR
• Patient Sex: Male