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

Catalog Number JHJR072502J

Device Problems Human-Device Interface Problem (2949); Material Protrusion/Extrusion (2979); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 07/29/2021

Event Type  Injury  

Event Description

The following information was reported: on an unknown date, this patient underwent an endovascular treatment and a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device /jhjr072502j) was implanted in superficial femoral artery.On an unknown date, lower limbs amputation was performed, leaving the patient without both legs below the knee.It was reported years of walking on the knees placed a load on the amputation site, which also stressed the distal end of the implanted vibahan device, causing the viabahn device became like a u-shape and was collapsed.Furthermore, due to the continued load, a part of the product was exposed to the outside of the patient body, and eventually infection was observed.The viabahn device was explanted and bypass surgery was subsequently 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.On (b)(6) 2019, the patient underwent an amputation of the left femoral.The amputation was performed in the middle of the femoral 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 by the thighs placed a load on the amputation site, also stressed the distal end of the implanted vibahan devices, causing the viabahn devices to form a u-shape from the middle of the device, and the bent part was confirmed to have moved to just under the subcutaneous tissue of the amputation site.It is unknown whether the viabahn devices moved with the native vessel or moved breaking through the native vessel, but since it is difficult to imagine the native vessel extending, reportedly that it was more likely to have broken through the vessel.There was no collapse of the viabahn devices.(it was reported that there was no blood flow in the viabahn devices after the amputation, and that they were probably occluded with some kind of plaque.Since the bent part of the viabahn device 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 devices and had spread to the native vessel in the proximal side of the viabahn device.Furthermore, an infected aneurysm was suspected in the native vessel, and the bleeding was thought to be from that 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).

Manufacturer Narrative

The second device (jhjr071002j) mentioned in the event description is captured in mrn - 2017233-2021-02402.

Manufacturer Narrative

Added d6a - date of implant (b)(6) 2019.

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.

• 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: marcos ayala ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12268620
• MDR Text Key: 264936724
• Report Number: 2017233-2021-02217
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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,Followup,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JHJR072502J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 61 KG