MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® PROPATEN® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Problem Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/06/2022

Event Type  Injury  

Manufacturer Narrative

Due to an unknown lot/serial number and no device return, an investigation could not be performed.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 information was reported to gore: on (b)(6) 2022, this patient underwent an emergency endovascular treatment for an arch aortic aneurysm rupture using gore® tag® conformable thoracic stent grafts with active control system (ctag-acs).The proximal device (tgmr373720j) was deployed just distal to the left common carotid artery.When a balloon was inflated at the overlap site of the two ctag-acs, the proximal end of the device moved distally about 1 cm.A type ia endoleak was then observed.To resolve the endoleak, the left subclavian artery was plug-embolized using an amplatzer vascular plug and additional stent grafts (zenith alpha extensions 38 mm and 42 mm) were implanted into the proximal site.The type ia endoleak was resolved.During the procedure, a left carotid-axillary bypass was constructed as well.Reportedly, the bypassing procedure was not related to the migration event of the ctag-ac.It was performed because no blood flow from left vertebral artery to the left subclavian artery was confirmed.A gore® propaten® vascular graft was used for the bypass.The propaten was kinked near the anastomosis site of the carotid artery, a bare-metal stent (smart, 8 x 40 mm) was implanted in the propaten graft.The patient tolerated the procedure.No injury to the patient was reported.The reporting physician commented as follows: although the space of the aneurysmal sac was taken into consideration, the proximal end was migrated more than expected.The proximal neck seemed shorter than the pre-operative measurement.

• Brand Name: GORE® PROPATEN® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• 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: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13424792
• MDR Text Key: 286742957
• Report Number: 2017233-2022-02709
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 02/02/2022
• Supplement Dates Manufacturer Received: 04/12/2022
• Supplement Dates FDA Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male