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

Model Number	FEM14060
Medical Device Problem Codes	Positioning Failure (1158); Material Perforation (2205); Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a stent graft placement in the left innominate vein via basilic outflow access in the left upper arm, the healthcare provider allegedly felt friction during the deployment attempt.Reportedly, the healthcare provider retracted the stent graft before it released from the inner catheter.Furthermore, a new device was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent graft placement in the left innominate vein via basilic outflow access in the left upper arm, the healthcare provider allegedly felt friction during the deployment attempt.Reportedly, the healthcare provider retracted the stent graft before it released from the inner catheter.Furthermore, a new device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: review of manufacturing records was not required, as no additional complaint has 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 all specifications prior to shipment.Investigation summary: a stent graft delivery system was returned for evaluation.On the basis of the returned stent graft delivery system, the alleged deployment failure could be confirmed.The outer sheath was found elongated, which indicated that increased friction affected the delivery system during attempt of stent graft deployment.Furthermore, the outer sheath was found perforated by stent graft strut, which made a stent graft deployment impossible.No indication was found for manufacturing related issues.As a result of the investigation performed the complaint is confirmed.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 anatomy of the placement site the ifu states: "the safety and effectiveness of the device when placed across a tight bend including the terminal cephalic arch or across the elbow joint 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." 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." h10: d4(expiry date: 11/2021), g4 h11: h3, h6(method, results, conclusion).

• 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: 8509359
• Report Number: 9681442-2019-00050
• Device Sequence Number: 16419978
• Product Code: PFV
• UDI-Device Identifier: 04049519008691
• UDI-Public: (01)04049519008691
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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: 11/02/2021
• Device Model Number: FEM14060
• Device Catalogue Number: FEM14060
• Device Lot Number: ANCY0420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1