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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE® PROPATEN® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
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.
 
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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 Key13424792
MDR Text Key286742957
Report Number2017233-2022-02709
Device Sequence Number1
Product Code DSY
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
K062161
Number of Events Reported1
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 Received02/02/2022
Supplement Dates Manufacturer Received04/12/2022
Supplement Dates FDA Received04/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
Patient SexMale
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