MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Device Problems Partial Blockage (1065); Deformation Due to Compressive Stress (2889)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/11/2023

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.Without a lot number or device serial number, the manufacturing date and/or production details cannot be determined, and the information provided to gore cannot be connected to a specific device.The device remains implanted and was, therefore, not available for analysis.No clinical images enabling direct assessment of product performance were returned for evaluation.Cause of the reported event cannot be established based on the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.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 literature was reviewed: rin hoshina, et al.Challenges in the management for cases of collapsed viabahn balloon-expandable endoprosthesis.The 87th annual scientific meeting of the japanese circulation society 2023: 87 p.(b)(4).We report a case of collapsed gore® viabahn® vbx balloon expandable endoprosthesis(vbx) in the bilateral common iliac arteries(cia) of an elderly patient with a bent back.An 80-year-old woman was referred to our hospital with a chief complaint of bilateral intermittent claudication.She had undergone endovascular therapy for the right cia with a balloon-expandable metal stent due to lower extremity occlusive atherosclerosis and percutaneous coronary intervention for asymptomatic myocardial infarction at the age of 75.Arterial echocardiography and a contrast-enhanced computed tomography(ct) showed obstructive lesions of bilateral cia.Kissing vbx stents were deployed in both cias, resulting in resolution of symptoms.Ten months later, the symptoms recurred, and ct revealed collapsed vbx stent surrounded by blood thrombus which might be caused by spinal compression of the vbx stent.Surgical thrombectomy was performed, and vbx stent was reinforced by lining bare nitinol self-expandable stent simultaneously, which resolved the patient's symptoms.Physicians should consider that a bent back could be the cause of vbx stent collapse even in the cia.Lining bare nitinol self-expandable stent in a vbx stent is one of solutions for collapsed vbx stent.

Manufacturer Narrative

A4: patient weight updated.Section h6 updated to reflect completion of investigation.Manufacturing records were reviewed, and the device's met all pre-release specifications.This investigation is considered complete.Two gore® viabahn® vbx balloon expandable endoprosthesis (serial#: (b)(6); udi#: (b)(4) and (serial#: (b)(6); udi#: (b)(4).Gore® viabahn® vbx balloon expandable endoprosthesis were implanted in same anatomical location, and it is unknown which device was the one that collapsed and occluded.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17791806
• MDR Text Key: 323966907
• Report Number: 2017233-2023-04293
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 40 KG