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

Catalog Number FAF08070

Device Problems Premature Activation (1484); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2014

Event Type  malfunction  

Event Description

It was reported that during deployment of a stent graft in the cephalic arch, the stent graft could only partially deploy approximately 1cm.The device was removed without incident and another stent graft was successfully deployed.There was no reported patient injury.

Manufacturer Narrative

The lot number was not provided; therefore, the device history records could not be reviewed.The investigation is currently underway.

Manufacturer Narrative

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 event reported to date for this lot number and failure mode.The stent graft returned for evaluation and was partially deployed and protruded approximately 5mm from the tip of the outer sheath.Sheath.During performance evaluation, an attempt was made to deploy the stent graft, however, this proved unsuccessful likely due to dried blood identified in the device.Based on the results of the evaluation, the investigation is confirmed for partial deployment, as the stent graft was returned partially deployed, however, the root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.The current ifu (instructions for use) state warnings/precautions.The stent graft (implant) cannot be repositioned after total or partial deployment.Once partially or fully deployed, the flair endovascular stent graft cannot be retracted or remounted onto the delivery system.Device removal after deployment can only be done with a surgical approach.Faulty placement techniques may lead to failure in stent graft deployment.The delivery system can function only after the red safety clip has been pulled off and the tuohy-borst valve is loosened.This should not be done until the stent graft is positioned across the lesion and is ready to be deployed.After full stent graft deployment, wait a few seconds to allow for complete device expansion before removing the delivery system over the guidewire.Additionally, specific potential complications and adverse events as well as directions for stent graft deployment are included in the ifu.

Manufacturer Narrative

To ensure compliance to 21 cfr 803.50 a retrospective review of this file was conducted to determine if good faith efforts were made to obtain the required information and/or an explanation of why any required information was not provided.Multiple follow up attempts were made with the facility to obtain any information pertaining to the patient, product, and/or procedural details (e.G.Date of the event, relevant test data, relevant history, lot #, catalog #, implant and/or explanted dates, and concomitant product(s) or therapy) that were not previously obtained during the initial investigation.The user facility was able to provide patient details of age, weight, sex and relevant history, which has been updated in the appropriate sections.

• Brand Name: FLAIR ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 3851223
• MDR Text Key: 4620945
• Report Number: 2020394-2014-00106
• 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,company representative,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2014

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 Catalogue Number: FAF08070
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2014
• Initial Date FDA Received: 03/25/2014
• Supplement Dates Manufacturer Received: 09/09/2015; 09/09/2015
• Supplement Dates FDA Received: 05/22/2014; 10/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 77 YR
• Patient Weight: 87