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

Catalog Number PAHR051002E

Device Problem Complete Blockage (1094)

Patient Problem Insufficient Information (4580)

Event Date 07/20/2021

Event Type  Injury  

Manufacturer Narrative

The occlusion of the viabahn® vbx device dated may 11, 2020, was reported to fda with mfr report #: 2017233-2020-00424.(b)(4).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 aortic repair (bevar) with a customized fenestrated / branched stent graft component (cook medical) because of a thoracoabdominal aneurysm type iii.The following branches were treated with one gore® viabahn® vbx balloon expandable endoprosthesis (viabahn® vbx device) each: celiac artery, right renal artery, superior mesenteric artery.A gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn® device) was used to treat the left renal artery.Access was gained via a cut down to the axillary artery to implant the viabahn® vbx devices and the viabahn® device.On (b)(6) 2020, the patient presented with a total occlusion of the right renal artery which was resolved during an endovascular reintervention on the same day.They performed a mechanical thrombectomy by aspiration using the penumbra system (penumbra inc.) and relined the lesion with a viabahn device.On (b)(6) 2021, the patient presented with a total re-occlusion of the right renal artery branch.

Manufacturer Narrative

B5: updated event description: h6-code 213: a review of the technical manufacturing records indicated the lot met all pre-release manufacturing specifications.H6-code 3233: a review of the sterilization and heparin coating manufacturing records is being performed.H6-code 4111: images have been requested for evaluation from the physician, but were not provided.Therefore an imaging evaluation could not be performed.In total two (2) reports related to this event are being submitted.- manufacturer report number 2017233-2021-02409.- manufacturer report number 2017233-2021-02410.

Event Description

On (b)(6) 2020, the patient underwent an endovascular branched aortic repair (bevar) with a customized fenestrated / branched stent graft component (cook medical) because of a thoracoabdominal aneurysm type iii.The following branches were treated with one gore® viabahn® vbx balloon expandable endoprosthesis (viabahn® vbx device) each: celiac artery, right renal artery, superior mesenteric artery.A gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn® device) was used to treat the left renal artery.Access was gained via a cut down to the axillary artery to implant the viabahn® vbx devices and the viabahn® device.On (b)(6) 2020, the patient presented with a total occlusion of the right renal artery which was resolved during an endovascular reintervention on the same day.They performed a mechanical thrombectomy by aspiration using the penumbra system (penumbra inc.) and relined the lesion with a viabahn device.On (b)(6) 2021, the patient presented with a total re-occlusion of the right renal artery branch.In (b)(6) 2021, the responsible physician re-evaluated the images related to this event.They stated, that according to his new assessment total re-occlusion of the right renal artery branch is procedure-related and not device related.

Manufacturer Narrative

H6-code 213: investigation summary: a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The device remains implanted in the patient.Therefore a device evaluation could not be performed.Images have been requested for evaluation from the physician, but were not provided.Therefore an imaging evaluation could not be performed.With no additional information provided, gore is unable to perform further investigations of this incident.Based on the event description and the subsequent investigation, we are unable to determine the cause of this incident and assign a root cause.

• 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: 12547019
• MDR Text Key: 273802980
• Report Number: 2017233-2021-02409
• 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: 01/14/2022

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
• Device Expiration Date: 09/24/2021
• Device Catalogue Number: PAHR051002E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 10/18/2021; 12/15/2021
• Supplement Dates FDA Received: 11/01/2021; 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2018
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 81 KG