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

Catalog Number JHJR071002J

Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Human-Device Interface Problem (2949); Material Twisted/Bent (2981)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/29/2021

Event Type  Injury  

Manufacturer Narrative

Additional 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

On (b)(6) 2019, this patient underwent an endovascular treatment for chronic limb threatening ischemia (clti).Two gore® viabahn® endoprostheses with heparin bioactive surface (viabahn device / jhjr072502j and jhjr071002j) were implanted in the left superficial femoral artery.On (b)(6) 2019, the patient underwent an amputation of the left leg.The amputation was performed in the middle of the femoral artery and the viabahn device was amputated as well.The viabahn device was implanted in the order of jhjr072502j and jhjr071002j from the proximal side, and was cut in the middle of jhjr071002j leaving about 2 cm of overlap with jhjr072502j.The cut end of the viabahn was sutured together with the native vessel.On (b)(6) 2020, the patient underwent an amputation of right femoral, leaving the patient without both legs from the middle of the femoral.In (b)(6) 2021 (the date is unknown), the patient presented a small amount of bleeding in the inguinal region and visited the hospital.Long-term walking placed a load on the amputation site, also stressed the distal end of the implanted vibahan device, causing the viabahn device to form a u-shape from the middle of the device, and the bent portion was confirmed to have moved to just under the subcutaneous tissue of the amputation site.It is unknown whether the viabahn device moved with the native vessel or moved breaking through the native vessel, however, since it is difficult to imagine the native vessel extending, it was reported that it was more likely to have broken through the vessel.There was no collapse of the viabahn device.It was reported that there was no blood flow in the viabahn device after the amputation, and that it was suspected to be occluded due to plaque.Since the bent part of the viabahn devices had migrated to just under the subcutaneous tissue of the amputation site, although it was not exposed, the site became ulcer-like.It was confirmed that infection had occurred with the viabahn device and had spread to the native vessel in the proximal side of the viabahn.Furthermore, an infected aneurysm was suspected in the native vessel, and the bleeding was thought to be from the aneurysm.On the same day, emergency surgery was performed, the viabahn devices were removed, and the native vessel was trimmed in a non-infected area and treated by patching (no bypass was performed).

Event Description

On (b)(6), 2019, this patient underwent an endovascular treatment for chronic limb threatening ischemia (clti).Two gore® viabahn® endoprostheses with heparin bioactive surface (viabahn device / jhjr072502j and jhjr071002j) were implanted in the left superficial femoral artery.

Manufacturer Narrative

The device (jhjr072502j) mentioned in the event description is captured in mrn - 2017233-2021-02217.Corrected b5.Corrected h6.

• 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
• MDR Report Key: 12530182
• MDR Text Key: 273315434
• Report Number: 2017233-2021-02402
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JHJR071002J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 61