MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT

Catalog Number JHH130502J

Device Problem Activation Failure (3270)

Patient Problems Perforation (2001); Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/29/2021

Event Type  Injury  

Manufacturer Narrative

(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

The following was reported to gore: on (b)(6) 2021, the patient developed a pseudoaneurysm from placement of a central venous catheter.On (b)(6) 2021, the patient presented with a pseudoaneurysm in the right subclavian artery and underwent endovascular treatment utilizing a gore¿ viabahn¿ endoprosthesis with heparin bioactive surface (vsx).The viabahn was inserted and advanced from the right brachiocephalic artery through a 12 fr sheath.Upon initiating deployment, the physician reportedly felt resistance but continued pulling the deployment line.The deployment line then broke leaving approximately 1cm of the vsx device undeployed.The physician made additional attempts to deploy the device by manipulating the delivery catheter, and using biopsy forceps but was unsuccessful.The attempts to complete deployment resulted in a bent strut on the vsx device.The physician then decided to cut the undeployed portion of the device to complete the procedure leaving the deployed portion in the patient.On (b)(6) 2021, the patient underwent reintervention for an axillo-femoral bypass.Thrombus was observed around the previously cut device in the subclavian artery and was removed without issue but the physician decided to leave the device in the patient.The physician then observed a vessel dissection in both the brachiocephalic artery and the left common carotid artery and stated the dissections possibly occurred while pulling the device with forceps on (b)(6) 2021.The physician will monitor the dissections.The patient tolerated the procedure.

Manufacturer Narrative

H6: investigation findings and investigation conclusion codes updated.Product investigation report conclusion: the manufacturing records were reviewed, and the device lot met all pre-release specifications.Product evaluation confirms partial deployment and a broken deployment line.The cause of the deployment resistance is unknown.

Manufacturer Narrative

H6 updated to reflect imaging evaluation.Review as follows: four time-points have been submitted to be evaluated: pre-implantation cta dated (b)(6) 2021, 2-movies containing intra-operative angiogram imaging, post-implantation cta dated (b)(6) 2021 and post-implantation cta dated (b)(6) 2021.Note: the length of the stent observed during imaging evaluation is 3-4cm compared to the 5cm labeled endoprosthesis length which indicates a partially expanded endoprosthesis.On the intra-operative angiogram (movie format) imaging of (b)(6) 2021: see timed details on the attached imaging evaluation for movie #1 and #2.On comparison axial images from (b)(6) 2021: on the right common carotid artery and the right subclavian artery appear to be dissected on the (b)(6) 2021 image set.There appears to be a stent implanted in the rsa on the (b)(6) 2021 time-points.The length of the stent appears to be ~3cm ¿ 4cm.There also appears to be an unidentified radiopaque density near the distal end of the implanted device on both time-points.The(b)(6) 2021 images appear to show: the presence of an axillo-axillary bypass.There appears to be ~7.7cm of rsa without flow, within the device and distal to it.Flow can be visualized distal to this level, to the bypass origin and distally.Product evaluation confirms partial deployment and a broken deployment line.The cause of the deployment resistance is unknown.Ifu statements: imaging and measurement - to ensure precise sizing and placement of the endoprosthesis, measure diameter of the target vessel or prosthetic graft, and lesion length using image-centered, magnified-view contrast angiography, including a marker guidewire or catheter.Native vessel diameter must be accurately measured, not estimated.When treating avg anastomosis stenosis, sizing of prosthetic graft lumen is performed.Precautions related to instructions for use - when implanting the stent graft, confirm the size of target vessel or prosthetic graft accurately.Physicians are encouraged to utilize the minimum number of devices with appropriate sizes to adequately cover the target lesion.Do not spot stent graft in multiple lesions.Sizing and selection of the product - measure the vessel or prosthetic graft diameter carefully and select the appropriate stent graft size.To assure adequate anchoring, the stent graft size of approximately 5¿20% larger than the healthy vessel diameter immediately proximal and distal to the lesion should be selected.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT
• 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: liam schultz ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11388175
• MDR Text Key: 239450852
• Report Number: 2017233-2021-01714
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2022
• Device Catalogue Number: JHH130502J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 01/29/2021; 01/29/2021
• Supplement Dates FDA Received: 10/06/2021; 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2019
• 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; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male