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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

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W.L. GORE & ASSOCIATES GORE® ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT Back to Search Results
Device Problem Occlusion Within Device (1423)
Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); Swelling (2091); Thrombosis (2100); Numbness (2415); Vascular System (Circulation), Impaired (2572)
Event Date 02/27/2014
Event Type  Injury  
Event Description
A physician reported a case in which following the gore® acuseal vascular graft implant, the patient developed arterial steal.On (b)(6) 2014, a gore® acuseal vascular graft was implanted as a left brachio-brachial forearm loop arteriovenous graft.Four days post implant the patient reported numbness but tolerating it well.On (b)(6) 2014, the patient experienced forearm swelling with low flows in the graft.A fistulogram and balloon angioplasty of the venous anastomosis with a 6mm balloon was performed.The patient had good result and had dialysis successfully thereafter.The patient returned on (b)(6) 2014 with hand pain and neurologic deficit.Axillary artery stenosis was treated on (b)(6) 2014, with a gore® viabahn® endoprosthesis but symptoms did not improve.The graft thrombosed a few days later but due to the worsening arterial steal and risk of hand loss, a decision was made not to salvage it.The patient¿s hand motor dysfunction exists to date, though gradually improving with physical therapy.The physician further reports, "this is an anticipated complication of all accesses, particularly in diabetic patients and these observations may just represent random non-significant events, falling within the accepted complication rates.".
 
Manufacturer Narrative
No testing methods performed.No results available since no evaluation performed.
 
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Brand Name
GORE® ACUSEAL VASCULAR GRAFT
Type of Device
PROSTHESIS, VASCULAR GRAFT
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MEDICAL WEST B/P
1505 n. fourth street
flagstaff AZ 86004
Manufacturer Contact
roger smith
1500 n. 4th street
flagstaff, AZ 86004
9285263030
MDR Report Key4775558
MDR Text Key5799890
Report Number2017233-2015-00292
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130215
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/20/2015
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 Not provided
Initial Date FDA Received05/15/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Required Intervention;
Patient Age45 YR
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