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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE-TEX® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER Back to Search Results
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Unspecified Infection (1930); Inflammation (1932)
Event Date 11/05/2021
Event Type  Injury  
Event Description
The following information was reported to gore: on an unknown date the patient was implanted with a gore-tex® vascular graft to treat an unknown etiology.On an unknown date the device was identified to be infected.A reintervention is planned for an unknown date.
 
Event Description
The following information was reported to gore: on an unknown date the patient underwent a femoral popliteal bypass using a gore-tex® vascular graft.On an unknown date the device was identified to be infected.On an unknown date the patient underwent a reintervention to removed the device.
 
Manufacturer Narrative
Patient id - (b)(6).
 
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Brand Name
GORE-TEX® 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
marcos ayala
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key12929859
MDR Text Key281741111
Report Number2017233-2021-02590
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K802095
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/07/2022
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 11/05/2021
Initial Date FDA Received12/03/2021
Supplement Dates Manufacturer Received04/07/2022
Supplement Dates FDA Received04/07/2022
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) Other;
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