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

Catalog Number HT084050J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Myocardial Infarction (1969)

Event Date 02/05/2020

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.As the devices were not returned, no evaluation of the devices could be performed.

Event Description

On an unknown date, previous to any gore device being implanted, the patient underwent treatment of an abdominal aortic aneurysm with a non-gore device.On (b)(6) 2020, the patient underwent treatment for a debranching bypass procedure (right axillary artery ¿ left common carotid artery, left axillary artery) using a gore® propaten® vascular graft.Next, the patient was treated for a thoracic aortic aneurysm using a conformable gore® tag® thoracic endoprosthesis with active control (ctag ac).It was reported the ctag ac was successfully deployed just below the brachiocephalic artery.The left subclavian artery was embolized as planned.The patient¿s vital signs reportedly became unstable (blood pressure decreased 70mmhg and jumped into 250 mmhg), and the procedure was temporarily stopped.It was reported the patient¿s vitals slightly recovered.No touch up ballooning was performed.The final angiography showed slightly insufficient wall apposition at the distal end of the ctag ac.However, there was no identified endoleak.The physician is reportedly going to monitor the apposition of the device.It was reported the patient did not wake up from the anesthesia due to a stroke (cerebral infarction) that occurred during the procedure.On (b)(6) 2020, the patient is reportedly still not awake.The physician stated it is suspected that the stroke occurred due to the debranching tevar procedure, however, the timing of the stroke could not be confirmed.Additionally, the physician stated the patient¿s vitals may have become unstable during the procedure due to the stroke.The physician reportedly stated the propaten and ctag ac functioned as expected with no malfunction of either device.

Manufacturer Narrative

Added method code 2.

Manufacturer Narrative

Additional manufacturing narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #6471934pp021.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9857390
• MDR Text Key: 194367735
• Report Number: 2017233-2020-00202
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2023
• Device Catalogue Number: HT084050J
• Device Lot Number: 6471934PP021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR