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

Model Number FAS07050

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.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 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 Description

It was reported upon removing the stent graft, a break was identified on the catheter.No further treatment was performed.There was no reported patient injury.

Manufacturer Narrative

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.This is the only complaint reported to date for this lot number and failure mode.One flair endovascular stent graft was returned for evaluation.The atraumatic tip and approximately 4.4cm of the inner lumen was found to be detached.Based on the returned sample condition, the investigation is unconfirmed for break and confirmed for detachment of device or device component.Excessive withdraw forces likely caused the inner catheter detachment.It is possible that patient and/or procedural issues contributed to the reported event.The definitive root cause is unknown.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

Event Description

It was reported upon removing the stent graft, a break was identified on the catheter.No further treatment was performed.There was no reported patient injury.

• Brand Name: FLAIR ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7887595
• MDR Text Key: 120699320
• Report Number: 2020394-2018-01735
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008950
• UDI-Public: (01)04049519008950
• Combination Product (y/n): N
• PMA/PMN Number: P060002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FAS07050
• Device Catalogue Number: FAS07050
• Device Lot Number: ANBZ0244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Date Manufacturer Received: 11/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1