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  

Manufacturer Narrative

Due to an unknown lot/serial number and no device return, an investigation could not be performed.The investigation could not confirm the cause of the reported issue for this event.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

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 july 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 results state in the three stenting patients, one ica/cca-related cbs patient died of rebleeding due to rupture of the distal carotid artery of the stent graft 22 days after the treatment of nasal bleeding with stenting.Since the author reported that the incident was not device-related and was related to progression of the disease, it is classified as a non-complaint.(b)(4).The third patient¿s stent was exposed to the oral cavity, because the carotid artery was occluded without rebleeding, still following up.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.Therefore, the cause wasn't established.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: 14306675
• MDR Text Key: 291483316
• Report Number: 2017233-2022-02901
• 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; 06/10/2022
• Supplement Dates FDA Received: 06/05/2022; 06/10/2022
• 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): Other; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male