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

Device Problem Positioning Problem (3009)

Patient Problem Skin Erosion (2075)

Event Date 07/01/2021

Event Type  Injury  

Event Description

The following information was received through literature ¿extracranial/intracranial vascular bypass in the treatment of head and neck cancer - related carotid blowout syndrome¿ published by laryngoscope 131:1548¿1556 (b)(6) 2021.The study was to investigate the endovascular intervention or extracranial/intracranial (ec/ic) vascular bypass in the management of patients with head and neck cancer-related carotid blowout syndrome (cbs).Thirty-seven patients were included.Of the 12 patients with ica/cca hemorrhage, 3 underwent endovascular stenting.A self-expanding viabahn covered stent (w.L.Gore & associates inc, flagstaff, az, u.S.A.) that preserves blood flow is used in selected cases of bleeding of ica, cca, or eca stem, which is too near cca to be embolized.The patient was a (b)(6) male who was admitted to the hospital for recurrence of right neck cancer 4 years after radiotherapy for nasopharyngeal carcinoma.The right neck ulcer had a sudden massive hemorrhage and the amount of bleeding was about 1,000 ml.Compression hemostasis, blood transfusion, and dsa angiography were performed.Dsa found bleeding at the bifurcation of the right common carotid artery, and the right internal carotid artery stent graft was placed.The patient did not rebleed after the operation.Due to the gradual exposure of the right neck blood vessel and vascular stent, the risk of rebleeding and death is extremely high (fig.3).Under general anesthesia, the left common carotid artery-right middle cerebral artery bypass graft and the right common carotid artery ligation were performed on the 55th day after placing the vascular stent.The left saphenous vein is used as a bypass material for the transcranial bypass.Intraoperative angiography showed smooth blood flow.Clamp the right intracranial internal carotid artery with a permanent aneurysm clip, and ligate the proximal end of the right common carotid artery, internal carotid artery, and external carotid artery (figs.4 and 5).Two weeks after the first operation, the extended resection of right neck mass, right pectoralis major myocutaneous flap repair, and ica stent resection were performed, and the patient¿s condition was stable (fig.6).2203-a:-other (endoprosthesis exposed).

Manufacturer Narrative

Update b1/2, g3.

Manufacturer Narrative

H6: 213-due to an unknown lot/serial number and no device return, an investigation could not be performed.The information reported in the complaint reports an off-indication use of the viabahn device per the device risk management file.H6: 50-the patients with poor prognosis may be more related to the advanced state of tumor disease.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: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14306135
• MDR Text Key: 293365723
• Report Number: 2017233-2022-02900
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 05/06/2022
• Supplement Dates Manufacturer Received: 06/01/2022; 06/09/2022
• Supplement Dates FDA Received: 06/05/2022; 06/09/2022
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male