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

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Due to an unknown lot/serial number and no device return, an investigation could not be performed.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

The literature article: ¿post-tracheostomy tracheoinnominate fistula: endovascular treatment¿ published by lisieux eyer de jesus was reviewed.The article was published online or accepted on october 2, 2020.The use of gore® viabahn® endoprosthesis with heparin bioactive surface was evaluated for tracheoinnominate fistula treatment.A single patient case report for a 3 year old female with the use of gore® viabahn® endoprosthesis with heparin bioactive surface was evaluated for tracheoinnominate fistula treatment.Description of malfunction: the patient was treated by the endovascular placement of four expanded polytetrafluoroethylene (ptfe)/nitinol stents (viabhan®) in the right carotid (5×50 and 6×100 mm) and right subclavian arteries (5×25 and 5×100 mm), crossing the transition to the ia in y configuration.A stent (5×25 mm) accidentally migrated, staying next to the iliac bifurcation.This dislocated stent was not retrieved, since the team considered that removal attempts implied an unfavorable risk-benefit ratio.

Manufacturer Narrative

Literature citation: jesus le, silva ewgmd, balieiro m, feldman k, dekermacher s.Post-tracheostomy tracheoinnominate fistula: endovascular treatment.Rev paul pediatr.2021 jul 7;40:e2020229.Doi: 10.1590/1984-0462/2022/40/2020229.Pmid: 34259783; pmcid: pmc8280763.Added b7: added patient's past medical history.Corrected h6: investigation findings - no findings available.Due to an unknown lot/serial number and no device return, an investigation could not be performed.

• 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: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15336665
• MDR Text Key: 300709089
• Report Number: 2017233-2022-03284
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 10/04/2022
• Supplement Dates FDA Received: 10/25/2022
• 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): Other; Hospitalization
• Patient Age: 3 YR
• Patient Sex: Female