MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number VBH090502A

Device Problems Sticking (1597); Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2017

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).Review of device manufacturing record history confirmed device met pre-release specifications.The device was not returned.Therefore, direct product analysis was not possible.Ifu method state, prior to implantation of the gore® viabahn® endoprosthesis with heparin bioactive surface, the physician should refer to the sizing table (table 1) and read the directions for use.Sizing table recommendation is to use 0.035" guidewire diameter.Ifu warnings state: special care should be taken to ensure that the appropriate size endoprosthesis, compatible sheath and guidewire are selected prior to introduction.Do not attempt to deploy the endoprosthesis or manipulate the delivery system without an appropriately sized guidewire (table 1) and fluoroscopic guidance.

Event Description

Patient presented for an arteriovenous access revision in the upper arm due to a fistula and stenosis.The intended treatment site had an existing bare metal stent (manufacturer unknown).It was reported the physician advanced the gore® viabahn® endoprosthesis without the aid of a sheath, over a.018 guidewire.The gore® viabahn® endoprosthesis reached the target site and the device partially deployed when the deployment line became stuck.The viabahn catheter was pushed forward and the gore® viabahn® endoprosthesis was able to be deployed some more before getting stuck again.The physician manipulated the catheter again in order to release the rest of the constrained gore® viabahn® endoprosthesis.However, the gore® viabahn® endoprosthesis moved more centrally, beyond the targeted landing zone.In order to remove the partially expanded gore® viabahn® endoprosthesis, the axillary vein was cut and the device was removed, along with the still attached deployment line.The vein was surgically repaired and the patient is recovering well.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6314517
• MDR Text Key: 66914659
• Report Number: 2017233-2017-00072
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: VBH090502A
• Device Lot Number: 14401412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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
• Treatment: .018 GUIDEWIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR