MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2020-02-29 for GORE PROPATEN VASCULAR GRAFT H060040A manufactured by W.l. Gore & Associates.
[188385663]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188385664]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00134 |
| MDR Report Key | 9772477 |
| Report Source | STUDY |
| Date Received | 2020-02-29 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-06 |
| Date Added to Maude | 2020-02-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SIBYLLE STAERK |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MEDICAL WEST B/P |
| Manufacturer Street | 1505 N. FOURTH STREET |
| Manufacturer City | FLAGSTAFF AZ 86004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 86004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE PROPATEN VASCULAR GRAFT |
| Generic Name | PROSTHESIS, VASCULAR GRAFT |
| Product Code | DSY |
| Date Received | 2020-02-29 |
| Catalog Number | H060040A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | FLAGSTAFF AZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-02-29 |