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

Catalog Number FAS08070

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

Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)

Event Date 09/03/2014

Event Type  malfunction  

Event Description

It was reported that during deployment of a stent graft in the brachiaral vein arch of a loop graft, the stent graft could only partially deploy approx 2 mm.The device was removed without incident and another stent graft was successfully deployed.There was no reported pt injury.

Manufacturer Narrative

The lot number has been provided and the device history records are being reviewed, the device has been returned for eval.The investigation is currently underway.

Manufacturer Narrative

The device history records have been reviewed and this lot met all release criteria.The device was returned evaluation.The stent graft was partially deployed and protruded approximately 10mm from the tip of the outer sheath.Bent struts noted on the deployed portion of the stent graft.Dried blood was present between stent graft and outer catheter.Several bent struts were found along the undeployed and deployed portions of the stent graft.The eptfe coating was noted to be pulled back at the bent struts.This may have been a result of retracting the partially released stent graft through the introducer sheath.Functional testing could not be performed, due to the dried blood in the device, the partially deployed stent graft could not be deployed.Based upon the returned sample condition, the complaint investigation is confirmed for a partial deployment of the stent graft.However, the root cause could not be determined based upon available info.It is unk whether pt and or procedural issues contributed to the event.The current ifu (instructions for use) state warnings: 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.

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 facility was able to provide patient information, which was 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: 4189288
• MDR Text Key: 5099843
• Report Number: 2020394-2014-00437
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2014

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 Expiration Date: 03/31/2017
• Device Catalogue Number: FAS08070
• Device Lot Number: ANYC1998
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/19/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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: 71 YR
• Patient Sex: Female