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

Model Number FEM12060

Device Problems Break (1069); Detachment of Device or Device Component (2907); Activation Failure (3270)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The lot number for the device was provided.The device history records and image are currently under review.The device was returned to the manufacturer for evaluation.The investigation is currently under way.

Event Description

It was reported that allegedly a part of the deployment system remained in the patient.Reportedly the stent graft was deployed in the subclavian vein.However, it looked as if the radiopaque marker was still on the stent; one end of the stent did not expand.When the stent graft delivery system was removed, the spring of the catheter was exposed.As reported an additional device was used to break open the marker and expand the stent.The stent remains in the patient.Reportedly there was no patient injury.

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: based on the evaluation of the device sample returned and the x-ray images provided, the alleged break respectively detachment of the tip could be confirmed.The tip of the 10f outer catheter, including the radiopaque marker band remained on the implanted stent graft and was broken by balloon so that the stent graft was expanded to its adequate diameter.Based on sample evaluation no indication was found that a manufacturing related issue may have caused the reported issue.Based on the information available, the reported issued was confirmed.However, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling supplied with this product 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." regarding the use of accessories the ifu states: "materials required for the fluency® plus endovascular stent graft procedure: (.) introducer sheath with appropriate inner diameter (.)".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." (b)(4).

Event Description

It was reported that allegedly a part of the deployment system remained in the patient.Reportedly the stent graft was deployed in the subclavian vein.However, it looked as if the radiopaque marker was still on the stent; one end of the stent did not expand.When the stent graft delivery system was removed, the spring of the catheter was exposed.As reported an additional device was used to break open the marker and expand the stent.The stent remains in the patient.Reportedly there was no patient injury.

Manufacturer Narrative

The lot number for the device was provided.The device history records and image are currently under review.The device was returned to the manufacturer for evaluation.The investigation is currently under way.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 allegedly a part of the deployment system remained in the patient.Reportedly the stent graft was deployed in the subclavian vein.However, it looked as if the radiopaque marker was still on the stent; one end of the stent did not expand.When the stent graft delivery system was removed, the spring of the catheter was exposed.As reported an additional device was used to break open the marker and expand the stent.The stent remains in the patient.Reportedly there was no 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: 8471742
• MDR Text Key: 140595697
• Report Number: 9681442-2019-00046
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008646
• UDI-Public: (01)04049519008646
• 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: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2021
• Device Model Number: FEM12060
• Device Catalogue Number: FEM12060
• Device Lot Number: ANCS2367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 04/01/2019
• Supplement Dates Manufacturer Received: 03/15/2019; 04/24/2019
• Supplement Dates FDA Received: 04/09/2019; 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention