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

Model Number	FEM08100
Medical Device Problem Codes	Positioning Failure (1158); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: based on the information available and the investigation performed, there is no indication that the product failed to meet its specification prior to shipment.The lot 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.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented that could have led to the event reported.Investigation summary: a stent graft delivery system was returned.Based on the evaluation of the returned sample the reported issue could be confirmed.The outer sheath was found to be elongated which indicated that high friction and high force was present during the deployment attempt; which led to subsequent fracture of the outer sheath and the impossibility to deploy the stent graft.An indication for a manufacturing related issue could not be identified.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: based on the lot number provided the following version of the instructions for use (ifu) was supplied with this product: b05667 rev.5/04-16 which is currently valid.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".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".
Event or Problem Description
It was reported during stent graft deployment in cephalic arch, the stent graft allegedly did not deploy.It was further reported that another stent graft was used to complete the procedure.There was no reported patient injury.

• Brand Name: FLAIR 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: 8131180
• Report Number: 2020394-2018-02160
• Device Sequence Number: 13847959
• Product Code: PFV
• UDI-Device Identifier: 04049519008516
• UDI-Public: (01)04049519008516
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P060002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2018

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: 04/06/2021
• Device Model Number: FEM08100
• Device Catalogue Number: FEM08100
• Device Lot Number: ANCR0761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR