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

Device Problem Migration (4003)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 09/18/2020

Event Type  Injury  

Manufacturer Narrative

As device remains implanted, a further investigation on the device cannot be performed.The author was contacted to ask for more details like event date, serial no., implant date as well as patient data and possible root causes.Date of event was determined as date when literature article was accepted, here september 18, 2020.As patient age (b)(6) was determined and as gender female as mentioned in the article.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 article was reviewed: ¿superficial femoral artery pseudoaneurysm and arterial wall destruction after drug-coated balloon treatment¿ published by valentin golouh from university medical centre maribor on september 18, 2020 as an open access case report at cureus 12(9): e10527.Doi:10.7759/cureus.10527.Lower extremity artery disease is estimated to affect approximately 202 million people worldwide, almost one-fifth of them in europe [1].Steno-occlusions are often multi-level, with complex calcified morphology [2].They are frequently located in the superficial femoral artery (sfa) in the adductor canal or the popliteal artery, where the anatomy of the region is unfavorable, as the vessels are exposed to constant dynamic forces [3-4].The 2017 european society of cardiology guidelines recommend the endovascular-first approach only in lesions shorter than 25 cm and the use of drug-coated balloon (dcb) as a consideration in some cases.In longer lesions, bypass surgery is the method of choice.The endovascular approach remains an alternative, as it is more challenging to perform, requiring by-pass landing zones to be protected and stenting avoided [1].Furthermore, traditional balloon angioplasty, where no stenting is performed after balloon dilatation of the occluded vessel, has up to 40%-60% restenosis, reocclusion, or symptom recurrence rates in complex lesions [5].In cases of insufficient recanalization, bailout stenting must be performed.Due to the suppression of intensive neointimal hyperplasia occurring after angioplasty, dcbs present a potentially cost-effective way to reduce the need for stenting and improve patency [3,6-7].However, concerns of potential paclitaxel toxicity with paclitaxel-coated balloons emerged recently [2].We present a case of a pseudoaneurysm after dcb angioplasty of an occluded sfa in the adductor canal.A (b)(6) woman with claudication underwent endovascular treatment.The left sfa was first dilatated with a 5 mm balloon catheter, and an additional dilatation with a 6 x 150 mm dcb was performed.Extravasate in the vicinity of the sfa was seen on the control angiography; therefore, a 6 x 150 mm viabahn stent-graft (gore medical, flagstaff, arizona) was inserted.No leakage was observed on the angiography, and the patient was discharged the next day.Two months later, the patient returned with edema of the left leg, which was painful upon palpation and spanned from the medial side of the knee towards the shin.A retraction of the stent-graft and a pseudoaneurysm were seen on computed tomography angiography (cta).A guidewire passage was performed through the inserted viabahn stent-graft and the pseudoaneurysm into the popliteal artery.Another viabahn stent-graft was then inserted.Lastly, both viabahn stent-grafts were overstented with a supera stent (abbott vascular, abbott park, illinois), to gain more radial force.

Manufacturer Narrative

Requests were emailed to the author to provide additional information like patient information, serial numbers, dates of procedure, onset date of occlusion, date of reintervention, imaging series, etc.The requests remained unanswered.The serial numbers remain unknown, therefore a review of the manufacturing records could not be performed.The devices remain implanted in the patients, therefore device evaluations could not be performed.With no additional information provided, gore is unable to perform further investigations of this complaint.This investigation is considered complete, the cause of the complaint was unable to be determined in the instruction for use for the gore® viabahn® endoprosthesis with propaten bioactive surface the following is stated: hazards and adverse events: procedure related: as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: malposition device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: migration.

• 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: 12299328
• MDR Text Key: 265799967
• Report Number: 2017233-2021-02229
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: SI
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

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: 07/16/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 03/29/2022
• Supplement Dates FDA Received: 03/30/2022
• 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
• Treatment: SUPERA STENT (ABBOTT VASCULAR); SUPERA STENT (ABBOTT VASCULAR)
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female