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

Model Number FAS07070

Device Problems Break (1069); Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2018

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.

Event Description

It was reported that during a stent deployment in left upper arm, the stent graft was allegedly unable to deploy.There was no reported patient injury.

Event Description

It was reported that during a stent deployment in left upper arm, the stent graft was allegedly unable to deploy.There was no reported patient injury.

Manufacturer Narrative

H10: 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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one flair endovascular stent graft was returned for evaluation.A break in the outer catheter was noted in the catheter reinforcement area.The stent graft was noted to be partially deployed approximately 0.6cm.Therefore, the investigation is confirmed for partial deployment and an outer catheter break.Potential factors which may have caused or contributed to the reported issue have been considered.Additional force was likely experienced while attempting to deploy the stent graft which ultimately caused a ductile break in the outer catheter.It was reported that the path was not torturous; therefore, it is unknown if patient factors contributed to the reported event.Insufficient flushing of the device may be a contributing factor; however, the user reported that the device was flushed and the lesion was pre dilated.A manufacturing related cause was considered, therefore, the lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Based on the information available, a definite root cause for the reported event could not be determined.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.

• 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: 8069809
• MDR Text Key: 127136754
• Report Number: 2020394-2018-02022
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008967
• UDI-Public: (01)04049519008967
• 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,other
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

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
• Device Operator: Health Professional
• Device Model Number: FAS07070
• Device Catalogue Number: FAS07070
• Device Lot Number: ANCT1561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/14/2018
• Supplement Dates Manufacturer Received: 01/07/2019
• Supplement Dates FDA Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR