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

Model Number	FAF07050
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Retraction Problem (1536); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2018
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, the stent graft was allegedly met with some resistance during deployment attempt and the delivery catheter allegedly broke.It was further reported that the stent graft allegedly did not deploy.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent graft placement procedure, the stent graft was allegedly met with some resistance during deployment attempt and the delivery catheter allegedly broke.It was further reported that the stent graft allegedly did not deploy.There was no reported patient injury.
Additional Manufacturer Narrative
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.This is the only complaint reported to date for this lot number and failure mode.The device was returned for evaluation.The device was visually evaluated and noted the outer catheter had a circumferential break.The inner lumen was also noted to be damaged/crimped.The device was unable to be functional tested.Therefore, the investigation is confirmed for break and material deformation as the inner lumen was crimped and the outer catheter was broke.The investigation is also inconclusive for partial deployment as the device was returned with the stent outside of the system.The investigation is also inconclusive for retraction issue as the event was unable to be reproduced.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(b)(4).

• 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: 7672245
• Report Number: 2020394-2018-01162
• Device Sequence Number: 751874
• Product Code: PFV
• UDI-Device Identifier: 04049519008790
• UDI-Public: (01)04049519008790
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/21/2018

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: FAF07050
• Device Catalogue Number: FAF07050
• Device Lot Number: ANAR1097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 70