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

Catalog Number FAS08070

Device Problems Break (1069); Positioning Failure (1158); Retraction Problem (1536); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2013

Event Type  malfunction  

Event Description

It was reported that during an attempt to implant a stent graft next to a previously implanted stent in the sfa using a contralateral approach, the stent graft could not be deployed.Additional force was applied to the delivery system until the outer sheath broke near the delivery handle.During retraction of the partially deployed stent graft, the eptfe covering was torn, exposing the stent struts.The stent graft system was removed in its entirety and another stent graft was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

A further clinical review of this event was performed and identified the event to be mdr reportable pursuant to 21 cfr part 803.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.The device was returned.The investigation is confirmed for partial deployment, as the stent was returned partially deployed.Additionally, the investigation is confirmed for partial deployment, as the stent was returned partially deployed.Additionally, the investigation is confirmed for deployment failure and outer catheter break.It was identified that the eptfe covering on the stent graft was torn and the stent struts were kinked.It should be noted that the device was used to treat an aneurysm in the sfa using a contralateral approach.

• Brand Name: FLAIR ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): ANGIOMED GMBH & CO MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe ; GM
• Manufacturer Contact: brett curtice ; 1625 west 3rd st; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4810770
• MDR Text Key: 21834327
• Report Number: 2020394-2015-00700
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: FAS08070
• Device Lot Number: ANWK0582
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/29/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1