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

Model Number	FAS07070
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2019
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 return of the device is pending.The investigation is currently under way.The information provided by bd 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 bd.
Event or Problem Description
It was reported that during deployment, the outer catheter of the endovascular stent graft allegedly came apart and the stent graft allegedly would not deploy.The system was removed from the patient without incident.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a dhr review was not required as this lot met all release criteria.There was nothing found to indicate a manufacturing-related cause for this event.Investigation summary: one flair endovascular stent graft was returned.The device was visually evaluated and found to have a break in the outer catheter and the stent graft had failed to deploy.Therefore, the investigation is confirmed for break and failure to deploy.Potential factors which may have caused or contributed to the reported issue have been considered.The reported type of event may be related to a difficult patient anatomy or a challenging placement site, which may have led to an increased friction force during deployment.Insufficient flushing of the device or use of inadequate accessories could be a contributing factor for the reported issue.It is unknown if the device was flushed prior to use.Outer catheter stretching was identified which indicates high frictional forces.The break is likely a result of additional force applied in an attempt to deploy the stent graft.However, the definitive root cause for the reported event could not be determined.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.
Event or Problem Description
It was reported that during deployment, the outer catheter of the endovascular stent graft allegedly fractured and would not deploy.Reportedly, the system was removed from the patient without incident.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: 8339504
• Report Number: 2020394-2019-00125
• Device Sequence Number: 2060759
• Product Code: PFV
• UDI-Device Identifier: 04049519008967
• UDI-Public: (01)04049519008967
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/26/2019

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 Model Number: FAS07070
• Device Catalogue Number: FAS07070
• Device Lot Number: ANCX0546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1