MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® HYBRID VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number 9MM

Device Problems Obstruction of Flow (2423); Patient-Device Incompatibility (2682)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 06/22/2023

Event Type  Injury  

Event Description

The following was reported to gore via ssb11-02 study: in (b)(6) 2018, cta and m2s reconstruction identified the patient to have a chronic debakey iii aortic dissection, from left subclavian artery to just distal to the left renal artery, with left kidney being perfused by the false lumen.Surgical intervention was recommended.On (b)(6) 2018, pre-operative diagnosis was residual dissection following type b dissection repair and zone 2 arch debranching.The patient underwent zone ii arch replacement and aortic valve resuspension.The carotid artery was bypassed using an 8mm limb with a 9mm gore® hybrid vascular graft that was implanted in the left common carotid artery.The innominate artery was sewn to the graft after re-cannulating the grafting and going back onto cerebral and systemic perfusion.The new dacron graft was anastomosed to the native sinotubular junction (stj) using a running 4-0 prolene suture.On march 30, 2022, the 48-month ct scan was performed.No occlusion was reported for the lcca occlusion.However, there was a double bend (kink) in the lcca proximal to the stented portion of the gore® hybrid vascular graft.The presence of this double bend in the vessel increases the potential for turbulent flow which likely contributed to the loss of lcca/gore hybrid graft patency at a later date.On june 22,2023, the tbe 60-month ct angiography was performed.Findings showed the left common carotid artery (lcca) and the gore® hybrid vascular graft occlusion with partially visualized trace distal reconstitution.Intervention, if any, was not reported for the occluded gore® hybrid vascular graft.

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Device lot/serial number was requested, but not made available.A review of device manufacturing record history could not be conducted.Device remains implanted; therefore, direct product analysis was not possible.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.

Manufacturer Narrative

B5: event description was updated.D4: catalog number was entered as 9mm.(lot/serial number; therefore full catalog number is unknown).

Event Description

The following was reported to gore via (b)(4) study: in (b)(6) 2018, cta and m2s reconstruction identified the patient to have a chronic debakey iii aortic dissection, from left subclavian artery to just distal to the left renal artery, with left kidney being perfused by the false lumen.Surgical intervention was recommended.On (b)(6) 2018, pre-operative diagnosis was residual dissection following type b dissection repair and zone 2 arch debranching.The patient underwent zone ii arch replacement and aortic valve resuspension.The carotid artery was bypassed using an 8mm thoracic aortic limb.A 9mm gore® hybrid vascular graft was implanted in the left common carotid artery (lcca).The innominate artery was sewn to the graft after re-cannulating the grafting and going back onto cerebral and systemic perfusion.On (b)(6) 2022, the 48-month ct scan was performed.No occlusion was reported for the lcca occlusion.However, there was a double bend (kink) in the lcca proximal to the stented portion of the gore® hybrid vascular graft.The presence of this double bend in the vessel increases the potential for turbulent flow which likely contributed to the loss of lcca/gore hybrid graft patency at a later date.On (b)(6) 2023, the tbe 60-month ct angiography was performed.Findings showed the gore® hybrid vascular graft in the left common carotid artery (lcca) occluded with partially visualized trace distal reconstitution.

• Brand Name: GORE® HYBRID VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19107442
• MDR Text Key: 340229306
• Report Number: 2017233-2024-04822
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K093934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2024

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 Catalogue Number: 9MM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 05/23/2024
• Supplement Dates FDA Received: 05/24/2024
• 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): Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 68 KG