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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2020

Event Type  Injury  

Manufacturer Narrative

Patient weight was unavailable.Implant date was unavailable.A review of the manufacturing records for the device was unable to be conducted as no lot number was available.Article citation: endovascular aortic arch reconstruction with parallel grafts: a dilemma of excessive endograft oversizing huey-shiuan kuo, et al.Doi: 10.6515/acs.202007_36(4).20200109a, acta cardiol sin 2020;36:351-359.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

The following information was received through literature ¿endovascular aortic arch reconstruction with parallel grafts: a dilemma of excessive endograft oversizing¿ published in acta cardiol sin.The study aimed to evaluate the safety and efficacy of a parallel graft technique to reconstruct the aortic arch.From august 2014 to july 2018, a total of 25 patients underwent thoracic aortic endovascular repair (tevar) with a zone 1 landing aortic stent graft (various brands), a chimney graft (viabahn device) to preserve the left common carotid artery, and a periscope graft (viabahn device) to preserve the left subclavian artery.The outcomes and complications were reported.Three years after the primary procedure, a type ia endoleak with persistent blood filling into the false lumen developed in a (b)(6) male patient with a chronic type b dissection, which was salvaged by embolization to the gutter.

Event Description

Author believes it was not relative with device instead of procedure and size selective in general in this literature, and he is satisfying on vsx outcome for those high-risk procedures.

Manufacturer Narrative

G3/4 - update combination product?-yes.It is unknown if these adverse events were related to the viabahn devices.Information was not made available.

• 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: 12369031
• MDR Text Key: 268209321
• Report Number: 2017233-2021-02307
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR