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

Model Number FEM14080

Device Problems Misfire (2532); Malposition of Device (2616); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.The information provided by bard 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 bard.

Event Description

It was reported that during a stent graft deployment procedure, the stent graft allegedly partially deployed.As a result the accuracy of placement allegedly was not ideal.Reportedly, another stent graft was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: based on the information available and the investigation performed, there is no indication that the product failed to meet its specification prior to shipment.The lot records have been 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.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.No additional complaint has been reported for this lot number previously.Investigation summary: a 10f stent graft delivery system was returned for evaluation.Based on the evaluation the reported partial deployment could not be confirmed as the stent graft was not returned.The outer sheath was found to be elongated, indicating that high deployment force was encountered during stent graft deployment.As it was reported that a 9f introducer sheath was used, although the delivery system requires a 10f introducer sheath, it is reasonably suggested that the use of an incompatible introducer sheath led to increased friction and subsequently high deployment force.Based on the event information provided and the evaluation of the sample returned, it is reasonably suggested that the reported difficulties occurred due to the used introducer sheath whose diameter was too small.Therefore, the reported issue was determined to be caused by using an incompatible accessory and is therefore closed to be use related.Labeling review: in reviewing the current labeling it was found that the instructions for use (ifu) sufficiently address the potential risk.The ifu 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." furthermore, the ifu 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." regarding the usage of accessories the ifu states: "materials required for the fluency® plus endovascular stent graft procedure: introducer sheath with appropriate inner diameter." in this case, a smaller sized introducer sheath was used.

Event Description

It was reported that during a stent graft deployment procedure, the stent graft allegedly partially deployed.It was further reported that after several minutes the stent graft could be deployed with high force.As a result, the accuracy of stent graft placement allegedly was not ideal.Another stent graft was used to complete the procedure as the location of the first stent graft was not ideal.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: 7915616
• MDR Text Key: 122162438
• Report Number: 2020394-2018-01803
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008707
• UDI-Public: (01)04049519008707
• 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
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FEM14080
• Device Catalogue Number: FEM14080
• Device Lot Number: ANCQ3744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Date Manufacturer Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1