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

Catalog Number FEM12100

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907)

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

Event Date 09/11/2020

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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiry date: 03/2023.

Event Description

It was reported that during a stent placement procedure through the left arm to access the cephalic arch stenosis, the stent allegedly deployed partially.The device was retracted with no reported patient injury.

Manufacturer Narrative

H10: the fda rn number for the initial mdr was inadvertently submitted as (b)(4).The correct fda rn number was (b)(4).H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot, previously.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 investigation of the returned sample, it was confirmed the outer sheath broke at the distal end, and that the tip detached and could be removed.In this case a system compatible guidewire and introducer sheath were being used.The vessel was not tortuous, and the lesion was predilated.The investigation break and detachment of the tip was confirmed.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 risk.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 the use of accessories, the ifu states: 'materials required for the fluency plus endovascular stent graft procedure: introducer sheath with appropriate inner diameter'; the packaging pictograms indicate a minimum introducer size of 10f.Furthermore, the instructions 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.' 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 through the left arm to access the cephalic arch stenosis, the stent graft allegedly was difficult to deploy; the sheath marker detached during deployment.The stent graft could be successfully deployed, and the device including marker were retracted using a snare with 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
• MDR Report Key: 10673664
• MDR Text Key: 213027649
• Report Number: 9681442-2020-20003
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FEM12100
• Device Lot Number: ANEQ4827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR