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

Model Number VBJR072502A

Device Problems Difficult or Delayed Activation (2577); Activation Failure (3270)

Patient Problem Hematoma (1884)

Event Date 09/28/2022

Event Type  malfunction  

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

The following was reported to gore: on (b)(6) 2022, a patient presented for treatment of peripheral arterial disease in the right lower superficial femoral artery utilizing a gore® viabahn® endoprosthesis with heparin bioactive surface.The calcified lesion was pre-ballooned prior to treatment.The physician loaded the viabahn device over an 0.014" guidewire and advanced to the area of treatment through a 7 fr sheath.When the physician pulled the deployment line the viabahn didn't deploy and there was no reported expansion.The physician then attempted to re-sheath the viabahn device for removal, but was unsuccessful.During attempts to remove the viabahn, the device expanded distally by approximately 4 cm within the patient.The partially deployed viabahn was removed from the patient along with the sheath.An alternate 6 x 25 viabahn device was used to complete the procedure utilizing a 0.035" guidewire without a sheath.Reportedly the patient experienced hematoma due to the event.

Manufacturer Narrative

Manufacturing records were reviewed and the device met all pre-release specifications.Product return evaluation: the evaluation of the returned device could not confirm the reported deployment failure as deployment could be successfully resumed at the knob without issue.The conditions present during the procedure cannot be replicated during evaluation, and no remarkable observations were noted during device evaluation with respect to the deployment functionality.Therefore, no primary device failure mode could be identified, and the root cause of the reported deployment failure could not be established with the available information.The partial endoprosthesis expansion and damage to the stent-graft observed during evaluation are consistent with the reported withdrawal of the device through the sheath.The gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use (ifu), for the appropriate region and time-period, was reviewed with respect to the complaint detail, and there are applicable statements.The ifu states the following: ¿do not withdraw the gore® viabahn® endoprosthesis with heparin bioactive surface back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore® viabahn® endoprosthesis with heparin bioactive surface back into the sheath can cause damage to the endoprosthesis, premature deployment, deployment failure, and / or catheter separation.If removal prior to deployment is necessary, withdraw the gore® viabahn® endoprosthesis with heparin bioactive surface to a position close to but not into the introducer sheath.Both the gore® viabahn® endoprosthesis with heparin bioactive surface and introducer sheath can then be removed in tandem.¿.

• 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: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15651009
• MDR Text Key: 302341964
• Report Number: 2017233-2022-03419
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132623792
• UDI-Public: 00733132623792
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 11/30/2022

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 Model Number: VBJR072502A
• Device Catalogue Number: VBJR072502A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 09/29/2022
• Supplement Dates FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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: Male
• Patient Weight: 113 KG