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

Model Number	FAF07070
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records were provided to the manufacturer.An image and photos of device 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 during stent graft deployment, the stent did not allegedly deploy and great resistance was felt.It was further reported that the coaxial end of the device was allegedly broken.There was no reported patient injury.
Event or Problem Description
It was reported during stent graft deployment, the stent did not allegedly deploy and great resistance was felt.It was further reported that the coaxial end of the device was allegedly broken.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 that there was a manufacturing-related cause for this event.One additional complaint has been reported for this lot number.Investigation summary: the flared flair endovascular stent graft was returned with one guided fluoroscopy image and one photo.Based on the medical image review, the identify of the vascular stent and vascular stent deployment could not be determined.An irregular radiopaque density was demonstrated at the distal tip of the deployment system suggesting a possible break.The photo depicted the coils of the delivery system and the stent graft was not visible in the photo.There is a small gap noted between the coils but the coils do not appear severely stretched or bent.The investigation is confirmed for failure to deploy as the catheter is bent 16.7 cm from the strain relief.It is possible that the user experienced high frictional deployment forces which led to the catheter becoming bent.High deployment forces and increased friction may be caused by a difficult patient anatomy, insufficient flushing of the device prior to use as well as use of inadequate accessories.However, based upon the available information, a definitive root cause could not be determined.The facts from the investigation have been evaluated and no additional action and/or corrective action is required at this time.Label review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Section a through f - 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.

• 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: 8126539
• Report Number: 2020394-2018-02151
• Device Sequence Number: 2364268
• Product Code: PFV
• UDI-Device Identifier: 04049519008806
• UDI-Public: (01)04049519008806
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P060002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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: FAF07070
• Device Catalogue Number: FAF07070
• Device Lot Number: ANCS0709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR