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

Model Number	FEL09120
Medical Device Problem Codes	Positioning Failure (1158); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records were provided, however, photos provided to the manufacturer and are under review.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 or Problem Description
It was reported that during treatment for a failed a/v graft procedure, the endovascular stent graft allegedly failed to deploy from the delivery system.It was further reported that the outer catheter sheath allegedly fractured.Reportedly, another endovascular stent graft was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during treatment for a failed a/v graft procedure, the endovascular stent graft (9x120) allegedly failed to deploy from the delivery system.It was further reported that the outer catheter sheath allegedly fractured.Reportedly, another endovascular stent graft of the same size (9x120) was used to complete the procedure, but same problem occurred.The physician was able to complete the procedure utilizing a 9x100 and a 9 x 40 endovascular stent graft of the same brand and type.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: 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 were no manufacturing anomalies or changes identified which may have caused or contributed to the reported event.No additional complaint has been previously reported for this lot number.Investigation summary: the stent graft delivery systems were not returned for evaluation.However, two photos of the devices were provided.The photos are showing the fractured outer sheath of two fluency plus delivery systems including the area of the y-adapter.Based on the photos the reported fracture of the outer sheath during the attempt to deploy the stent graft was confirmed.However, based on the available information, 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 risks.Regarding preparation of the device 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 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: "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.".

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7813422
• Report Number: 2020394-2018-01552
• Device Sequence Number: 1263777
• Product Code: PFV
• UDI-Device Identifier: 04049519008226
• UDI-Public: (01)04049519008226
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P130029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: FEL09120
• Device Catalogue Number: FEL09120
• Device Lot Number: ANZF3604
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR