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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
Model Number HT087080A
Device Problem Material Separation (1562)
Patient Problems Hemorrhage/Bleeding (1888); No Code Available (3191)
Event Date 12/17/2020
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) 2020, the patient presented with an unknown etiology in the femoral artery and underwent treatment utilizing a gore® propaten® vascular graft.The physician completed the implanting procedure successfully.While the patient was in post operative recovery, it was observed that the gore® propaten® vascular graft had reportedly torn above the distal anastomosis post operatively.Further information has been requested but is not available at this time.
 
Manufacturer Narrative
The following fields were updated to reflect additional information received: h6: clinical code, impact codes, type of investigation, investigation findings and investigation conclusions updated to reflect additional information received and completion of investigation.
 
Event Description
The following was reported to gore: on (b)(6) 2020, the patient presented with peripheral arterial disease in the femoral arteries and underwent an aortobifemoral bypass utilizing a gore® propaten® vascular graft.The physician completed the implanting procedure successfully.While the patient was in post operative recovery, it was observed that the patient was bleeding and was taken back to the operating room.The physician observed that the gore® propaten® vascular graft appeared torn from the anastomosis in the profunda post operatively.The physician made the following observations: part of the gore® propaten® vascular graft was still connected to the artery, and when the gore® propaten® vascular graft reportedly broke it retracted back into the tunnel that was created for placement.The physician then decided to ligate the gore® propaten® vascular graft and closed off the profunda.The procedure was completed by performing an above knee amputation.The patient tolerated the procedure and is reported to be recovering.
 
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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
liam schultz
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key11194486
MDR Text Key227553460
Report Number2017233-2021-01608
Device Sequence Number1
Product Code DSY
UDI-Device Identifier00733132606849
UDI-Public00733132606849
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K062161
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/08/2021
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? No
Device Operator Health Professional
Device Expiration Date06/28/2024
Device Model NumberHT087080A
Device Catalogue NumberHT087080A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/18/2020
Initial Date FDA Received01/19/2021
Supplement Dates Manufacturer Received12/18/2020
Supplement Dates FDA Received11/08/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/29/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient SexMale
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