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

Catalog Number	FAF08070
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: based upon the severity level and lot quantity, a dhr review is not required.Per the lot history review, this is the first complaint for this lot number and issue to date.Visual inspection: the sample was returned.The safety clip was missing upon receipt.The tuohy borst valve was tight, and the two-way stop cock was open.The outer catheter and metal tube were noted to be bent throughout the length.The outer catheter was noted to be stretched throughout the length of the delivery system.There was a gap of 2mm between the atraumatic tip and the distal end of the catheter.No other anomalies were noted to the outer catheter.Dried blood was observed between the outer catheter and the stent graft.Bent struts were noted throughout the undeployed stent graft.Functional/performance evaluation: an attempt to deploy the stent graft was not successful due to the dried blood.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the investigation is confirmed for deployment failure based on the condition of the returned sample.In addition, the stent graft could not be released during functional testing.The definitive 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 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 an attempt to implant an endovascular stent graft in an a-v graft at the anastomosis of the axillary vein, the stent graft allegedly would not deploy.It was further reported that the stent graft was removed from the patient without incident.Reportedly 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 west 3rd st.; tempe AZ 85281
• MDR Report Key: 5501938
• Report Number: 2020394-2016-00264
• Device Sequence Number: 213659
• Product Code: MIH
• UDI-Device Identifier: 04049519008844
• UDI-Public: (01)04049519008844(10)ANXK0641
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P060002/S027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/16/2015

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 Catalogue Number: FAF08070
• Device Lot Number: ANXK0641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2015
• Initial Report FDA Received Date: 03/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0223-2016
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 47