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

Model Number FAS07070

Device Problems Break (1069); Positioning Failure (1158); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2018

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 that the proximal end of the endovascular stent graft catheter allegedly broke as an attempt was made to deploy the stent graft.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the lot number was provided and the lot device history records have been reviewed.The 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 that has been reported for this corporate lot number to date.Investigation summary: one flair endovascular stent graft was returned for evaluation.The visual inspection noted a break in the outer catheter and partial deployment of the stent.Complete functional testing was unable to be performed due to the catheter break.Therefore, the investigation is confirmed for break and partial deployment.However, the investigation is inconclusive for difficult to advance due to returned sample condition.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: 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 that the proximal end of the endovascular stent graft catheter allegedly broke as an attempt was made to deploy the stent graft in the cephalic vein in a tortuous vessel.It was also reported that there was difficulty in advancing the delivery system to the target lesion and excessive force was necessary while attempting to deploy the stent graft.There was no reported difficulty in retracting the device from the patient.Reportedly, another stent graft delivery system was used to complete the procedure.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: 7695907
• MDR Text Key: 114291304
• Report Number: 2020394-2018-01226
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• 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: ANBT2952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Date Manufacturer Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1