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

Model Number	FAS08050
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2019
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 device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during a stent graft placement procedure in a severely stenosed left cephalic arch via access through a left cephalic dialysis fistula, the tip of the delivery catheter allegedly broke and became stuck in the treatment site after deployment of the stent graft.Therefore, the delivery system was difficult to remove from the patient.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: one flair endovascular stent graft delivery system was returned.The investigation is confirmed for break as the catheter is bent 14.2 cm from the strain relief and the distal tip likely separated from the delivery system as it was not returned.The investigation is inconclusive for difficult to remove as conditions of use could not be recreated.The root cause could not be determined based upon available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: g4 h11: h3; h6 (results, conclusion).H11: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.
Event or Problem Description
It was reported that during a stent graft placement procedure in a severely stenosed left cephalic arch via access through a left cephalic dialysis fistula, the tip of the delivery catheter allegedly broke and became stuck in the treatment site after deployment of the stent graft.Therefore, the delivery system was difficult to remove from the patient.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: 8291396
• Report Number: 2020394-2019-00092
• Device Sequence Number: 2462652
• Product Code: PFV
• UDI-Device Identifier: 04049519008998
• UDI-Public: (01)04049519008998
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: FAS08050
• Device Catalogue Number: FAS08050
• Device Lot Number: ANCS1475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR