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

Catalog Number FEM14040

Device Problems Fracture (1260); Material Perforation (2205); Misfire (2532)

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

Event Date 09/28/2020

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.(expiration date: 02/2023).

Event Description

It was reported that during treatment, the stent allegedly failed to deploy from the delivery system.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

Event Description

It was reported that during treatment, the stent allegedly failed to deploy from the delivery system.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

H10: 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 investigation of the returned catheter sample it was confirmed that the user could only partially deploy the stent graft.The deployment mechanism was found in used condition, and one stent graft strut was found perforating the outer sheath in the tip section which made stent graft deployment impossible.An indication for a manufacturing related cause could not be found.Potential factors which may have caused or contributed to the reported issue have been considered.Therefore, previous investigations of similar complaints have been reviewed.During evaluation it was found that the stent graft could not be deployed because a stent graft strut was perforating the distal outer sheath of the delivery system.This issue may be associated with challenging placement site leading to increased friction and subsequent damage of the outer sheath.Insufficient flushing of the device prior to use may be a contributing factor to increased friction; using an inappropriate accessories may be another contributing factor.In this case, the device was flushed, a 10f introducer sheath was used initially and was removed for stent insertion; the tracking vessel was not tortuous and/ or calcified.As a result of the investigation performed the complaint is confirmed for strut perforation and partial deployment.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential risk.The instructions 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 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.' 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.' under materials required the instructions for use states 'introducer sheath with appropriate inner diameter' and the packaging labels state a minimum introducer size of 10f.H10: d4 (expiry date: 02/2023), g3.H11: h6 (device, result, conclusion).H11: section a through f ¿ the information provide by bd represents all 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 : see h10.

• 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: 10827836
• MDR Text Key: 215913220
• Report Number: 2020394-2020-20419
• 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: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FEM14040
• Device Lot Number: ANEP4862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 96