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

Catalog Number FAF08070

Device Problems Break (1069); Premature Activation (1484); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that during use in an av fistula, the stent graft partially deployed.Additional attempts were made to deploy the stent graft until the outer sheath broke.Another stent graft was used to complete the procedure.There was no patient injury reported.

Manufacturer Narrative

A manufacturing review could not be performed as the lot number is unknown.The device has been returned to the manufacturer for evaluation.The investigation is currently underway.

Manufacturer Narrative

A manufacturing review was conducted.The lot met all release criteria.This is the first complaint reported for this lot number to date for deployment issue.The investigation is confirmed for partial deployment, as the stent graft was returned partially deployed.It should be noted that an outer shaft break is also confirmed as the outer sheath was torn off at the catheter reinforcement area.Per the reported event details, a 7 french introducer sheath was used to advance the device.The ifu states under "materials required for placement" that a 9f introducer sheath is required for device placement.As the 7 french sheath was used at the initial advancement and it is smaller in diameter, it is highly likely that use of the device within a smaller sheath size than indicated, contributed to the reported deployment issues.However, the definitive root cause is unk.

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 health professional at the user facility did not have any additional details to provide at this time.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.

• 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 AZ 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 4576255
• MDR Text Key: 5557168
• Report Number: 2020394-2015-00110
• 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,hea
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2015

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 Expiration Date: 06/30/2017
• Device Catalogue Number: FAF08070
• Device Lot Number: ANYF2027
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2015
• Initial Date FDA Received: 02/25/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/24/2015; 11/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0223-2016
• Patient Sequence Number: 1