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

Catalog Number VBJR061502W

Device Problem Activation Failure (3270)

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

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

Heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.A2, a3, a4: patient age, gender and weight are not available.H6: the device has not been returned yet and will be evaluated upon return.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) 2024, a patient was to be implanted with a 6mm x 15cm gore® viabahn® endoprosthesis with heparin bioactive surface (vsx device) to treat left superficial femoral artery (sfa) peripheral arterial occlusive disease (paod).A boston v18 guidewire and a terumo sheath were used.During the deployment process in order to expand the vsx device, the deployment line was stuck when it was pulled out about 30cm.The vsx device was not able to be deployed.Therefore, physician withdrew the delivery system used another same model of device to successfully complete the procedure.Patient tolerated the procedure and did not experience adverse consequences.The observed partial expansion of vsx device was occurred after it was moved from patient.

Manufacturer Narrative

D9: returned device was received by manufacturer.G2: report source is updated.H6: code c19 - a review of the manufacturing records indicated the device met pre-release specifications.Device engineering evaluation: the engineering evaluation details observations made directly on the returned device in addition to device photos captured during evaluation.Evaluation of the returned device indicates a partially deployed and expanded endoprosthesis, with tension on the deployment line between the transition and endoprosthesis.Several of the proximal facing strut tips of the distal strut row were outwardly bent, leading to a bunching of end tape on those specific apices.The distal shaft at the transition is also exposed.Continued deployment of the endoprosthesis was possible during the evaluation with traction at the knob.The reported failure mode of partial deployment due to a stuck deployment line is not consistent with the findings of an ability to continue deployment of the partially deployed endoprosthesis during engineering evaluation.The root cause of the observed bent struts at the distal end of the device with corresponding bunching of the end tape could not be established with the available information.Code d15 - investigation summary: procedural and benchtop deployment of the device can be impacted by different factors including but not limited to zipper integrity, delivery system support or stiffness, or presence of dried fluid on the device.The investigation could not confirm the cause of the reported hazardous situation nor assign a primary device failure mode.The primary reported complaint of vsx device partial deployment with a stuck deployment line could not be independently confirmed.The vsx device as returned was partially deployed with partial expansion of the endoprosthesis.However, it was reported that this expansion occurred after removal of the vsx device from the patient.Deployment of the returned vsx device was able to continue when pulling the deployment line from the knob, demonstrating that the deployment mechanism itself was not stuck.Replication of deployment issues during evaluation is not always possible as clinical factors (e.G.Patient anatomy, procedural conditions) cannot be replicated in the laboratory environment.The root cause of the partial deployment with stuck deployment line could not be established with the information available.

• 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: 18755319
• MDR Text Key: 336530975
• Report Number: 2017233-2024-04643
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: TW
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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 Catalogue Number: VBJR061502W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• 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: V-18 WIRE, TERUMO 7FR SHEATH