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

Model Number	FEM10060
Medical Device Problem Codes	Positioning Failure (1158); Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that during a stent graft placement procedure the stent graft allegedly failed to deploy from the delivery system.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: manufacturing record review was not performed, as the information available does not reasonably suggest a manufacturing process may have caused or contributed to the reported event.Investigation summary: a stent graft delivery system was returned.Based on the evaluation of the returned sample the reported issue was confirmed.The stent graft was found not deployed and a strut of the stent graft was found perforating the distal end of the outer sheath, which made 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 current 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 vascular 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: "prior to stent graft deployment (.), ensure that the proximal stent graft end is positioned in a straight section of the lumen to reduce the risk of increased deployment forces and possible failure to deploy." additional narrative: date received by mfr.Corrected data: device evaluated by mfr, evaluation codes (results, conclusion).
Event or Problem Description
It was reported that during a stent graft placement procedure the stent graft allegedly failed to deploy from the delivery system.There was no reported patient injury.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Common Device Name: ENDOVASCULAR STENT GRAFTS
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8624607
• Report Number: 2020394-2019-00581
• Device Sequence Number: 16717585
• Product Code: PFV
• UDI-Device Identifier: 04049519008592
• UDI-Public: (01)04049519008592
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

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: FEM10060
• Device Catalogue Number: FEM10060
• Device Lot Number: ANCY0390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1