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

Catalog Number VBJ060502

Device Problems Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 03/03/2014

Event Type  Injury  

Event Description

Patient presented with an in-stent restenosis.A 6fr introducer sheath was used to advance a 6x5 gore viabahn endoprosthesis over an.014 guidewire.The gore viabahn endoprosthesis was unable to reach the target site.The deployment line got hung up on a stent strut.In the process of advancing the gore viabahn endoprosthesis, the iliac artery was perforated.The constrained gore viabahn endoprosthesis was removed through the introducer sheath and was discarded.A 7fr introducer sheath was used to advance a second (6x10) gore viabahn endoprosthesis over an.035 guidewire to treat the perforated vessel.Some bleeding was observed after the gore viabahn endoprosthesis was deployed.The patient was transferred for an open surgical repair.

Manufacturer Narrative

Manufacturing report #2017233-2014-00165 was submitted for second device used during same procedure.Review of device manufacturing record history confirmed device met pre-release specifications.Warnings section of ifu states: w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore viabahn endoprosthesis in applications where the device is deployed within stents or stent grafts other than the gore viabahn endoprosthesis.Other devices may interfere with the deployment of the gore viabahn endoprosthesis resulting in deployment failure or other device malfunction.

• 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: genevieve begay ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3715010
• MDR Text Key: 4249529
• Report Number: 2017233-2014-00164
• 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: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: VBJ060502
• Device Lot Number: 11874007
• 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: 10/21/2013
• 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: GORE VIABAHN ENDOPROSTHESIS, LOT 12060761
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR