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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 H470045A
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2022
Event Type  malfunction  
Event Description
After the implantation of a gore propaten heparin vascular graft to the left upper arm, it was observed by the surgeon that the graft was "sweating" through.The surgeon had never observed this before and expressed a questioning attitude.After consulting with his fellow vascular surgeons, he notified the company from which the graft originated.The surgeon was told that the graft was defective, and it was decided that the graft would be removed and replaced with another.Surgery concluded with no further incident.The patient was transferred to the recovery room in stable condition.
 
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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 north fourth st.
flagstaff AZ 86004
MDR Report Key14102082
MDR Text Key289318885
Report Number14102082
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberH470045A
Device Catalogue NumberH470045A
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/01/2022
Event Location Hospital
Date Report to Manufacturer04/13/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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