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

Catalog Number FEM14120

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Material Deformation (2976)

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

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 12/2023).

Event Description

It was reported that during stent deployment procedure, the stent allegedly migrated on patient.It was further reported that physician trying to cover an aneurysmal av access and the stent jumped on him during deployment and during removal stent elongated.The stent was removed with out any difficulty.There was no reported patient injury.

Event Description

It was reported that during stent deployment procedure, the stent allegedly migrated on patient.It was further reported that physician trying to cover an aneurysmal av access and the stent jumped during deployment and during removal stent elongated.The stent was removed with out any difficulty.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.Investigation summary: the returned sample analysis could not be performed as the physical device was not returned and no images were provided.Insufficient flushing of the device before use or inadequate accessories may be contributing factors to the reported issue.The information about the flushing of the device or the placement site is not specified.The device was allegedly removed from the vessel and the stent was not deployed inside the patient, therefore there was not migration of the stent or any pieces of the stent after the procedure was aborted.However, the information is incomplete and there is not sufficient evidence to confirm any of the reported issues.Based on the investigation of the provided information, the investigation is closed as inconclusive.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 the warnings, the instructions for use states: 'do not use the device in patients where full expansion of an appropriately sized angioplasty balloon could not be achieved during pre-dilation.' also during deployment 'do not attempt to move the implant during or after deployment'.Regarding the precautions prior deployment and sizing the instructions for use states: 'faulty placement techniques may lead to stent graft deployment failure', and '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 indications for use state: 'the safety and effectiveness of the device when placed across an aneurysm or a pseudoaneurysm has not been evaluated'.The packaging pictograms indicate an introducer size of 10f and a 0.035" guidewire.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.

Manufacturer Narrative

H10: manufacturing review: 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 returned sample analysis could not be performed as the physical device was not returned and no images were provided.The device was allegedly removed from the vessel and the stent was not deployed inside the patient; therefore, there was not migration of the stent or any pieces of the stent after the procedure was aborted.However, the information is incomplete and there is not sufficient evidence to confirm any of the reported issues.The device was used to cover an aneurysm, which is off-label use.Based on the investigation of the provided information, the investigation is closed as inconclusive.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 the warnings, the instructions for use states: 'do not use the device in patients where full expansion of an appropriately sized angioplasty balloon could not be achieved during pre-dilation.' also during deployment 'do not attempt to move the implant during or after deployment'.Regarding the precautions prior deployment and sizing the instructions for use states: 'faulty placement techniques may lead to stent graft deployment failure', and '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 indications for use state: 'the safety and effectiveness of the device when placed across an aneurysm or a pseudoaneurysm has not been evaluated'.The packaging pictograms indicate an introducer size of 10f and a 0.035" guidewire.H10: d4 (expiry date: 12/2023),.

Event Description

It was reported that during stent deployment procedure, the stent allegedly migrated on patient.It was further reported that physician trying to cover an aneurysmal av access and the stent jumped during deployment.The stent was removed without any difficulty.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
• MDR Report Key: 11804751
• MDR Text Key: 249963344
• Report Number: 2020394-2021-01002
• 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,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FEM14120
• Device Lot Number: ANEZ2907
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other