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

Model Number	FAF07070
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2018
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 device was returned to the manufacturer for evaluation.The investigation is currently underway.(expiry date: 05/2021).
Event or Problem Description
It was reported during stent graft placement, a great resistance was allegedly identified therefore, the stent was removed.It was further reported that upon removal, a fracture was identified on the rear end of the catheter.There was no reported patient injury.
Event or Problem Description
It was reported during stent graft placement, a great resistance was allegedly identified therefore, the stent was removed.It was further reported that upon removal, a fracture was identified on the rear end of the catheter.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 there was a manufacturing-related cause for this event.Investigation summary: the device was returned for evaluation.The device was visually evaluated and the outer catheter had a circumferential break.The device was unable to be functional tested.Therefore, the investigation is confirmed for break as the outer catheter was broke.The investigation is unconfirmed for fracture as the device was actually broke.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.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.

• 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: 8258698
• Report Number: 2020394-2018-02329
• Device Sequence Number: 13979595
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 01/09/2019
• Initial Date Received by Manufacturer: 12/24/2018
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1