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

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.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9772477
• MDR Text Key: 188385663
• Report Number: 2017233-2020-00134
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• 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 Number: H060040A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/29/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/13/2020; 05/15/2020; 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 80