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

Catalog Number	FAS07050
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was conducted.The lot met all release criteria.Visual/microscopic inspection: the device was returned used.The safety clip was missing upon receipt.The tuohy borst valve was loose and the two-way stop cock was not returned.The gray outer sheath was torn off approximately 54mm from the proximal end of the handle at the catheter reinforcement area.The stent graft was in place and not released.There was a gap between the atraumatic tip and the distal end of the outer catheter of 4 mm.It was noted that the inner catheter was kinked at the gap.Functional/performance evaluation: functional testing could not be performed, as the delivery system was returned with the outer sheath broken.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the investigation is confirmed for deployment failure due to catheter breakage, as the stent graft was still in place in the delivery system, and the outer sheath was elongated and torn off at the catheter reinforcement area.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current flair endovascular stent graft instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.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 use in an a/v graft, the endovascular stent graft allegedly would not deploy.It was further reported that the system was retracted without incident and another endovascular stent graft was used to complete the procedure.There was no reported patient injury.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 west 3rd st.; tempe AZ 85281
• MDR Report Key: 5486339
• Report Number: 2020394-2016-00246
• Device Sequence Number: 423936
• Product Code: MIH
• UDI-Device Identifier: 04049519008950
• UDI-Public: (01)04049519008950(17)180529(10)ANZE2152
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P060002/S002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/19/2016

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: 05/29/2018
• Device Catalogue Number: FAS07050
• Device Lot Number: ANZE2152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2016
• Initial Report FDA Received Date: 03/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 109