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

Catalog Number PAC131002

Device Problems Migration or Expulsion of Device (1395); Sticking (1597)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/06/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, a gore® viabahn® endoprosthesis with propaten bioactive surface was used for the treatment of a lesion caused by weber syndrome.Femoral access was performed on the right side ipsilateral to the lesion.A 13mm x 10cm device was advanced over a cook amplantz guidewire.The deployment was performed by two operators, one physician holding the introducer catheter and the other one pulled the simpull deployment knob.It was reported to gore that the device deployed normally but as the deployment line was being removed, it was stuck on the gore® viabahn® endoprosthesis.It appeared that continued movement of the deployment line may cause the device to migrate.It was decided to cut the deployment line since the endoprosthesis was fully deployed and continue deploying three more of the same sizes proximally as was originally planned.The devices were deployed without any issues.The deployment line remained in the patient, trapped between the viabahn® devices and the wall of the artery.

Manufacturer Narrative

Concomitant medical products: (b)(6) 2015 cook amplantz guidewire, three additional gore® viabahn® endoprosthesis with propaten bioactive surface a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remained implanted; consequently, a direct product analysis was not possible.Without additional information it is impossible to further investigate this event.

• 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 86001
• Manufacturer Contact: sandra whicker ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4825518
• MDR Text Key: 21467333
• Report Number: 2017233-2015-00336
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2018
• Device Catalogue Number: PAC131002
• Device Lot Number: 13554755
• 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: 02/16/2015
• 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
• Patient Age: 29 YR