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

Model Number	FAS08050
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Separation (1562); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records were provided to the manufacturer.Images were provided.The lot number for the device was provided.The device history records and image are currently under review.The device was returned to the manufacturer for evaluation.The investigation is currently under way.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 a stent graft placement procedure in the cephalic fistula, the stent graft was allegedly partially deploy.It was reported excessive force was applied to deploy the stent graft.It was further reported that half of the stent was allegedly stuck into the sheath and the other half was sticking out.Another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the stent was returned for evaluation without the delivery system.Visual evaluation identified bent struts and peeled outer graft at the same location of bends.Holes in the graft were also noted throughout the length of the stent.Therefore, the investigation is confirmed for hole in material and delamination as the graft had holes and the outer graft was peeling from the inner layer at the bent struts.However, the investigation is inconclusive for partial deployment as the stent was fully deployed and the delivery system was not returned for evaluation.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that during a stent graft placement procedure in the cephalic fistula, the stent graft was allegedly partially deploy.It was reported excessive force was applied to deploy the stent graft.It was further reported that half of the stent was allegedly stuck into the sheath and the other half was sticking out.Another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: FLAIR ENDOVASCULAR STENT GRAFT
• Common Device Name: STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7825334
• Report Number: 2020394-2018-01584
• Device Sequence Number: 1290936
• Product Code: PFV
• UDI-Device Identifier: 04049519008998
• UDI-Public: (01)04049519008998
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 11/27/2018

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 Model Number: FAS08050
• Device Catalogue Number: FAS08050
• Device Lot Number: ANBP1154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 11/04/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 73