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

Model Number FEL10080

Device Problems Positioning Failure (1158); Fracture (1260); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2017

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 return of the device is pending.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 the endovascular stent graft allegedly fractured when the health care provider was attempting to deploy the stent graft in the left internal iliac artery.It was further reported that the stent graft partially deployed about a quarter from the delivery system before the outer catheter sheath fractured.Reportedly, the delivery system with the stent graft was removed without incident and replace with another to complete the procedure.The patient was hemodynamically stable at the conclusion of the procedure.

Manufacturer Narrative

Manufacturing review: a manufacturing related cause was considered.The lot history 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.There was no manufacturing anomalies or changes which may have caused or contributed to the reported event.No additional complaint has been reported for this lot number previously.Investigation summary: based on the condition of the returned sample the reported failure to deploy the stent graft was confirmed.The stent graft was found partially deployed and the outer sheath was found elongated which indicates that increased friction affected the delivery system during attempt of stent graft deployment and finally led to the fracture of the outer sheath.This fracture makes a stent graft deployment impossible.As a result of the investigation performed the complaint was confirmed.The reported application represents an off label use of the device.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding preparation of the device the ifu states 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 ifu states: "the safety and effectiveness of the device when placed across a tight bend (.) has not been evaluated.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" and "do not kink the delivery catheter or use excessive force during delivery to the target lesion." furthermore, 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." the reported application represents an off label use of the device.Based on the ifu supplied with this product the fluency® plus endovascular stent graft is indicated for use in the treatment of in-stent restenosis in the venous outflow of hemodialysis patients (.) and for the treatment of stenosis in the venous outflow of hemodialysis patients.

Event Description

It was reported that the endovascular stent graft allegedly fractured when the health care provider was attempting to deploy the stent graft in the left internal iliac artery.It was further reported that the stent graft partially deployed about a quarter from the delivery system before the outer catheter sheath fractured.Reportedly, the delivery system with the stent graft was removed without incident and replace with another to complete the procedure.The patient was hemodynamically stable at the conclusion of the procedure.

• 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
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6933276
• MDR Text Key: 89138468
• Report Number: 2020394-2017-01311
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008257
• UDI-Public: (01)04049519008257
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2018
• Device Model Number: FEL10080
• Device Catalogue Number: FEL10080
• Device Lot Number: ANZF2073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/09/2017
• Supplement Dates Manufacturer Received: 11/23/2017
• Supplement Dates FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR