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

Device Problem Obstruction of Flow (2423)

Patient Problems Stenosis (2263); Obstruction/Occlusion (2422)

Event Date 06/08/2023

Event Type  Injury  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the case number.A2 / a3: the patients mean age is 70 years and the gender male as stated in the article.B3: date of event was determined as date when literature article was published online, here june 8, 2023.H3 other code: as the devices availability remains unknown, no further investigation can be performed.Product history review: a review of the manufacturing records for the devices could not be conducted because the serial/lot numbers remain unknown.Further details were requested from the corresponding author such as serial no's., implant dates, date of events, patient id's, age, gender and weight, medical history of patients and possible root causes.Until now no further information was provided.Further investigation is being conducted and will be included in the final report.Heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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 a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.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 following literature article was reviewed:¿ is the mid-term patency rate of small-diameter viabahn stent-grafts in peripheral artery disease related to their length? a systematic review¿ published online june 8, 2023, by enrico ferrari et al.In the journal of endovascular therapy 00(0), pages 1-10.Small diameter endografts can be used for the treatment of peripheral vascular disease, but the patency rate during the follow-up is still under debate.With this review, we aimed at analyzing the mid-term patency of small diameter viabahn stent-grafts and investigating the relationship between patency and the length of the graft.The literature search yielded 128 publications both in pubmed and medline databases.We screened them by title/abstract and full text analysis.As a consequence of this analysis, 23 publications focusing on =7-mm diameter viabahn stent-grafts for the treatment of a peripheral artery disease were included in the study, spanning a period of time ranging from 2006 to 2020.Of the 23 publications, 16 retrospective and 7 prospective were found, including 1613 patients in total (1087 males), with mean age of 69.2 years.The peripheral artery disease involved the fpa (femoral popliteal artery), the fpa with in-stent restenosis, or the sfa (superficial femoral artery).The average length of the vascular lesion was 18.7±10.2 cm.The viabahn graft diameter ranged from 5 to 7 mm and the mean stent-graft length was 23.6±12.4 cm.The total number of stent-grafts was not available in selected papers.Among all stent-grafts used, the nonheparinized viabahn grafts were 53.6% while the heparin-bonded viabahn grafts accounted for 46.4%.Mean follow-up time was 26.4±17.6 months (1-year, 3-year, 5-year).Four studies (603 patients) did not report complications and re-inventions during the follow-up.A total of 309 cases of postoperative graft occlusions or restenosis were reported in the remaining 1010 cases , with 26 cases occurring within 30 days from the index procedure or in the early postoperative time.Among the 309 cases, 217 underwent re-interventions during the follow-up: fibrinolysis or thrombolysis, bypass surgery, thrombectomy, thrombectomy + viabahn implantation, implantation of additional stent-grafts, implantation of bare nitinol stent, balloon angioplasty, endovascular recanalization, atherectomy, cryoplasty, endarterectomy, and other.Twelve cases were watched closely, or the offered treatment was refused by the patient.Details on reintervention procedures were not reported for 80 cases.The main findings of the study can be summarized as follows: 1.The primary patency rate was up to 70% at 1 year and 50% at 5 years.The secondly patency rate was up to 90% and 80% at 1 and 5 years, respectively.2.Postoperative graft occlusion rate or restenosis was reported up to 30%, and 8% occurred within the first 30 days.The use of small diameter stent-grafts for peripheral vascular disease is an established technique but the patency rate is still under debate.With this review we have investigated the relationship between the mid-term patency and the diameter of the stent-grafts.After having analyzed data from 23 published studies including 1613 patients, we can conclude that the treatment of the peripheral artery disease with small diameter stent-grafts is safe, and the mid-term patency rate seems not be affected by the length of the grafts.

Manufacturer Narrative

Neither clinical images enabling direct assessment of product performance, nor the products were returned for evaluation.Further details were requested from the corresponding author such as serial no's., implant dates, date of events, patient id's, age, gender and weight, medical history of patients and possible root causes.The author stated that this is a review paper based on published papers.They can only see events described by other centers that have been already published and are available in pubmed.He cannot answer our questions.With the information provided to gore, the root causes of the reported events cannot be established.H6 evaluation codes investigation findings c20 was selected because no device investigations were able to be performed as no further information was able to be obtained from the authors and we did not receive the devices back for evaluation.In the instruction for use for the gore® viabahn® endoprosthesis with propaten bioactive surface the following is stated: adverse events possible adverse events and complications that may occur with the use of any gore® viabahn® endoprosthesis with propaten bioactive surface or in any endovascular procedure and require intervention include, but are not limited to: occlusion (thrombosis and/or stenosis) of endoprosthesis or vessel.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17681114
• MDR Text Key: 322610162
• Report Number: 2017233-2023-04250
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• 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: 10/30/2023
• 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: 70 YR
• Patient Sex: Male