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

Catalog Number PAHR080502E

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

In total four (4) medwatch reports related to this event are being submitted.All reports refer to the same patient identifier.The manufacturer report numbers are not available at the time of submission.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

On (b)(6) 2020, the patient underwent an endovascular branched endovascular aortic repair (bevar) with a customized fenestrated/ branched stent graft component (cook medical) because of a thoracoabdominal aneurysm type iv.The following branches were treated with one gore¿ viabahn¿ vbx balloon expandable endoprosthesis (viabahn¿ vbx device) each: celiac artery, left renal artery, right renal artery, and superior mesenteric artery.A gore¿ viabahn¿ endoprosthesis with propaten bioactive surface (viabahn¿ device) was used to extend the viabahn¿ vbx device implanted in the superior mesenteric artery distally.Access was gained via a cut down to the axillary artery to implant the viabahn¿ vbx devices and the viabahn¿ device.Reportedly, the procedure was very complex because of the anatomy.A very small endoleak occurred at the ostium of the left renal artery which was resolved during the procedure.They suspected that a pre-existing large calcification at the ostium of the left renal artery may have contributed to this small endoleak.On (b)(6) 2021, the patient was diagnosed a type 2 endoleak related to the customized fenestrated/ branched stent graft component (cook medical), a type 3 endoleak from the left renal artery branch, a type 1c endoleak from the superior mesenteric artery branch, and a stenosis (50 %) of the celiac trunk branch.Reportedly, they suspected that these complications may be related to the complex procedure and the pre-existing large calcification.Reportedly, they do not suspect the complications to be caused by the implanted devices.They noted that this anatomical location is also stressed by respiratory motion which may have favored the formation of the endoleaks and the stenosis of the celiac trunk.On (b)(6) 2021, an endovascular reintervention was performed to resolve the endoleaks and the stenosis successfully.It was stated that the event was resolved without sequelae.

Manufacturer Narrative

H6-code 213: a review of the manufacturing records indicated the device met pre-release specifications.H6-code 4111: requests were emailed to the physician to provide dicom images (pre, peri/intra, post) for evaluation.The requests remained unanswered.Therefore an imaging evaluation could not be performed.With no additional information provided, gore is unable to perform further investigations of this event.Four (4) devices are involved in this event.Therefore, in total four (4) medwatch reports have been submitted: manufacturer report number 2017233-2021-02419.Manufacturer report number 2017233-2021-02416.Manufacturer report number 2017233-2021-02417.Manufacturer report number 2017233-2021-02418.

Manufacturer Narrative

H6-code 4111: the user reported that they suspect the complications to be related to the complex procedure and anatomy and not caused by the implanted devices.Dicom images (pre, peri/intra, post) have been requested from the physician for evaluation.The requests remained unanswered.With no additional information provided gore was unable to perform further investigation of this incident.The cause of the endoleak could not be confirmed.

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12553183
• MDR Text Key: 274037019
• Report Number: 2017233-2021-02417
• 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,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2022
• Device Catalogue Number: PAHR080502E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2019
• 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): Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 86 KG