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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES GORE PROPATEN VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT Back to Search Results
Catalog Number H060040A
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Bacterial Infection (1735); Post Operative Wound Infection (2446)
Event Date 01/06/2020
Event Type  Injury  
Manufacturer Narrative
The lot number the device remains unknown.Segment of the study conduit was explanted and sent for pathology.The results have been requested but not yet provided to gore.
 
Event Description
This clinical trial case concerns a (b)(6) year old white male subject (b)(6).A study conduit was placed in his left upper arm on (b)(6) 2017.On (b)(6) 2020, 1085 days after the study conduit was surgically inserted, the patient experienced severe infection of the vascular access and was subsequently hospitalized.Reportedly, the patient presented with erythema, swelling and local pain over the study conduit.Temperature was 36.9° celsius.An ultrasound examination showed "fullness" around the study conduit, in the region of the skin erythema.The study conduit appeared compressed by the "fullness" in this segment.It was stated, that particles moved inside the "fullness" without flow on doppler.It was reported, that the patient was initiated with amoxicillin/clavulanate and ciprofloxacin.A temporary jugular catheter was placed for dialysis.On (b)(6) 2020, blood cultures yielded staphylococcus lugdunensis.On (b)(6) 2020, aspiration cultures from the site of infection subsequently yielded staphylococcus lugdunensis.On (b)(6) 2020, the patient reported improvement of the swelling and pain.Amoxicillin/clavulanate and ciprofloxacin were discontinued and intravenous cefazolin was started.On (b)(6) 2020, the patient underwent dialysis via temporary jugular catheter.On (b)(6) 2020, 1094 days after the study conduit was surgically inserted, the patient experienced severe vascular access site bleeding which required urgent surgery and prolonged hospitalization.A wound in the skin with necrotic margins and unhealthy subcutaneous tissue that seemed infiltrated was noted.An incision was made in the arm over the study conduit in the region of the wound.The study conduit was disconnected from the surrounding tissue and perforated.There was separation toward the anastomosis until reaching a healthy region in which the study conduit was seen well-adhering to the tissue.There was no need to perform separation around the anastomosis.Closure of the study conduit in this region was performed, leaving a small part of the study conduit in the region of the arterial anastomosis that appeared healthy and well connected to the tissues.Following this, good brachial and radial pulses were ascertained.Next, completion of the separation toward the upper arm was performed, and another incision was made in the middle of the arm above the study conduit, in the skin and subcutaneous tissue.Separation of the study conduit was done until reaching a region that was well-adherent and with healthy surrounding tissue.Incision and disconnection and removal of this segment of the study conduit was performed and sent for pathology.In the region of the skin and subcutaneous tissue that appeared infected, debridement was performed and the tissue was sent for pathology, and subsequently yielded staphylococcus lugdunensis.Anaerobic culture results were pending at the time.The site was rinsed with povidone/iodine and hemostasis was obtained with no active bleeding.Following the procedure, both of the events were considered resolved.On (b)(6) 2020, the patient underwent placement of a permacath and the temporary dialysis catheter was removed.On (b)(6) 2020, the patient was discharged from the hospital in stable condition.He had no fever throughout hospitalization.The surgical wound in the arm was without discharge or signs of infection and a pulse was palpated in the hand.The infectious disease physician recommended continuation of cefazolin treatment 2 g after dialysis for 8 weeks due to s.Lugdunensis, and follow up with the infectious disease physician.
 
Manufacturer Narrative
A2: patient age was corrected.
 
Manufacturer Narrative
Code 4111: laboratory results were shared with w.L.Gore and associates.The actual device was not returned for investigation.- laboratory results dated (b)(6) 2020, showed white blood cells (wbc) 7.46 x10e3/ul (normal range [nr]: 4-10.8).- on (b)(6) 2020, wound swab culture was negative.The event of infection of vascular access was considered resolved.- anaerobic culture of tissue obtained on (b)(6) 2020 showed no growth of anaerobic bacteria on (b)(6) 2020 and no growth of bacteria on (b)(6) 2020.Code 213: since there is no actual device available, nor pictures of the device, an explant evaluation could not be performed.A review of the manufacturing records could not be performed as the lot number remains unknown.Without additional information, gore was unable to do further investigation of this event.
 
Manufacturer Narrative
Additional manufacturer narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #unknown.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
 
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Brand Name
GORE PROPATEN VASCULAR GRAFT
Type of Device
PROSTHESIS, VASCULAR GRAFT
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
MDR Report Key9772477
MDR Text Key188385663
Report Number2017233-2020-00134
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
PMA/PMN Number
K062161
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Type of Report Initial,Followup,Followup,Followup
Report Date 08/05/2020
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 Catalogue NumberH060040A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/29/2020
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Supplement Dates FDA Received05/13/2020
05/15/2020
08/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age59 YR
Patient Weight80
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