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

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Stenosis (2263); Obstruction/Occlusion (2422)

Event Date 09/12/2020

Event Type  Injury  

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.A list of baseline characteristics for the complications group has been provided in the article.No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.The mean age of the 54 included patients was stated to be 71.5 years.The article states that 37 of the 57 patients were male.The date of incident is unknown.Therefore, the date the article was published online was used.

Event Description

The following publication was reviewed: ¿long-term outcomes after thoracic endovascular aortic repair using chimney grafts for aortic arch pathologies: 10 years of single-center experience¿ (wael ahmad et.Al, annals of vascular surgery, 2021, published online september 12, 2020).This retrospective, single-center study reports the early- and long-term outcomes of the thoracic endovascular aortic repair using the chimney-graft technique (chtevar) for the treatment of aortic arch pathologies between january 2010 and december 2019.Aortic arch repair with a chtevar was performed in 54 patients.Specifically, 13 chtevar patients received a cg in the lcca (proximal landing zone i), 1 patient in the brachiocephalic trunk (bct), and 38 patients received 2 cgs for the lcca and the bct (proximal landing zone 0).Additional 2 patients received a cg in the left subclavian artery.The ctag was used as the main aortic stent graft in all patients.An gore® excluder® aaa iliac limb was used as a cg in the bct; a gore® viabahn® endoprosthesis (n = 50) or a advanta v12® (n = 3) as a cg in the lcca (n=51) or in the left subclavian artery (n=2).The performed chtevar procedure is described in the article: the 10-15% oversized covered stent ¿ either an advanta v12® or gore® viabahn® endoprostheses was introduced through the left common carotid artery (lcca) into the ascending aorta and a gore® excluder® aaa endoprosthesis iliac leg was introduced via the brachiocephalic likewise into the ascending aorta.Similarly, a conformable gore® tag® thoracic endoprosthesis (ctag) was simultaneously introduced via the femoral approach until the proximal landing zone (0 or 1) was reached.The ctag was oversized between 20-30% for an aorta with degenerative aneurysm and 10% for a dissected aorta.The chimneys were introduced slightly deeper into the ascending aorta than the ctag, with an overlapping length of 3-5cm.The ctag was deployed, directly followed by the deployment of the chimney grafts, which was completed by balloon modeling.The article considers the advanta v12®, gore® viabahn® endoprosthesis and gore® excluder® aaa endoprosthesis as chimney-grafts (cg).Among others, the following adverse events were reported in the article for early postoperative outcomes: 6 patients had permanent neurological deficit including a major stroke.Of patients who developed stroke 5 patients had two cgs for bct and lcca and one patient had cg for lcca.It was stated that 2 patients had permanent neurological deficit including paraplegia.No patient specific information regarding the reported events and interventions was provided in the article.

Manufacturer Narrative

The author provided individual patient information (included case complication, age, gender, co-morbidities) related to the reported adverse events within the article.Therefore, individual cases have been created and have bee reported on for the mentioned viabahn devices.This duplicate report 2017233-2021-02129 is being retracted.The reported ¿neurological deficit including a major stroke¿ in the article are reflected in the following gore complaints/ medwatch reports: mpdcase-(b)(4) ¿ mw# 2017233-2021-02267.Mpdcase-(b)(4) - mw# 2017233-2021-02266.Mpdcase-(b)(4) - mw# 2017233-2021-02265.Mpdcase-(b)(4) - mw# 2017233-2021-02264.Mpdcase-(b)(4) - mw# 2017233-2021-02263.Mpdcase-(b)(4) - mw# 2017233-2021-02262.

• 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: jörg kersten ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12106623
• MDR Text Key: 259595812
• Report Number: 2017233-2021-02129
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• 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: 06/03/2021
• 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: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male