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

Catalog Number VBH110502W

Device Problems Material Separation (1562); Separation Failure (2547); Malposition of Device (2616); Detachment of Device or Device Component (2907); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

The following was reported to gore: on (b)(6) 2021, a patient was to be implanted with a 11mm x 5cm gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) to treat common iliac aneurysm.The patient's left common iliac aneurysm was ruptured and bleeding.Due to patient iliac artery anchoring area was too short, physician planned to place the anchoring area in the lower segment of abdominal aorta and to perform double iliac kissing technique.During the procedure, the guide wire was advanced to the lesion successfully.The 11mm x 5cm viabahn device and a 13mm x 10cm viabahn device were advanced through 12f long sheath at bilateral, with the proximal end at the same level in the abdominal aorta.Both deployment lines were pulled at the same time.The left 13mm x 10cm viabahn device expanded successfully.But the right 11mm x 5cm viabahn device was not enable to complete full expansion when it has been expanded about 80%.The physician pulled with higher force and completed the deployment, but device migrated.The deployment line cannot be pulled again and delivery system cannot be separated and removed.The delivery system and sheath were advanced forward, physician used a balloon to support dilatation but deployment line still cannot be pulled, device migrated again.Physician believed the deployment line was stuck at the end of device, therefore he cut the deployment line and removed delivery system, placed another 13mm x 5cm viabahn device at the proximal end.A 9mm x 8cm bare stent to placed at distal end to secure deployment line, avoiding deployment line drifting in the vessel.Patient tolerated the procedure.

Manufacturer Narrative

G3/g4: correction, combination product? - yes.A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Imaging evaluation: the image appears to demonstrate the proximal r viabhan is slightly distal to the vbh deployed in the left common iliac.The other images lack detail as to original deployment and can not be evaluated.Image depicts an inflated pta balloon.The images received cannot be used to perform a full imaging evaluation.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the available images provided for review.Gore cannot guarantee the images provided are accurate or lack alteration.Therefore, gore cannot guarantee all key findings have been captured or that the findings are accurate.

Manufacturer Narrative

The deliver catheter was discarded at hospital facility and was not made available for evaluation.The investigation, including evaluation of images, confirms the reported subsequent device migration, but could not confirm the cause for the reported partial deployment issue.Therefore, cause of the event cannot be established based on the available information.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: qiong wang ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12335280
• MDR Text Key: 267040892
• Report Number: 2017233-2021-02281
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2022

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: 12/11/2023
• Device Catalogue Number: VBH110502W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 08/02/2021; 03/15/2022
• Supplement Dates FDA Received: 11/26/2021; 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: 12F LONG SHEATH, COOK12F LONG SHEATH, GOLD LABELED; 12F LONG SHEATH, COOK12F LONG SHEATH, GOLD LABELED
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 55 KG