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

Catalog Number FEM14120

Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/20/2021

Event Type  Injury  

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, the photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 12/2023).

Event Description

It was reported that during a stent placement procedure, the stent allegedly difficult to deploy.It was further reported that the device allegedly had malposition failure.There was no reported patient injury.

Event Description

It was reported that during a stent graft placement procedure the stent graft allegedly experienced difficulty during deployment and malpositioned.Reportedly, the patient was scheduled for an additional procedure.The current patient status is unknown.

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 sample was returned to the manufacturer for evaluation.Based on the investigation of the returned sample, no stent was found in the system as it reportedly had been deployed inside patient.The investigation is closed as confirmed for 'difficult or delayed positioning', as an elongation was visualized on the outer sheath, indicating high release force; the issue is inconclusive for 'malpositioning' as no x-ray images were provided.No manufacturing issues were identified.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product it was found that the instructions for use sufficiently address the potential risks.Regarding preparation of the device the instructions for use state that '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.' 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.' the instructions for use further state in regards to accessories: 'the use of an appropriately sized introducer sheath is recommended.' regarding the precautions 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'.The packaging pictograms indicate an introducer size of 10f and a 0.035" guidewire.H10: d4 (expiry date: 12/2023), g3 , 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.

• 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: 11824529
• MDR Text Key: 250608468
• Report Number: 2020394-2021-01047
• 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: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FEM14120
• Device Lot Number: ANEZ2907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 88