MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-10-08 for EPICEL AU201 manufactured by Vericel Corporation.
[28447706]
Expired [death]. Case description: this spontaneous device case from united states was received on (b)(6) 2015 from a healthcare professional. This case concerns a (b)(6) male pt who expired after grafting with 48 sheets of epicel cultured epidermal autografts (epicel). No medical history, past drugs, concurrent conditions, concomitant medication were reported. The pt had received the graft following thermal burns to 76% of the body surface area. The skin biopsy of the pt has been taken on (b)(6) 2015. On (b)(6) 2015, the pt was grafted with 48 sheets of epicel grafts batch/lot number ee01947a. On (b)(6) 2015, the pt expired. Further details including description of clinical presentation, signs, symptoms, baseline data, diagnosis, cause of death and autopsy results were not reported. Outcome: fatal. Seriousness criterion: death. The reporter did not provide the causal relationship between the event and epicel grafts. However, as per the conditions of the humanitarian device exemption, that "unless death is specifically reported as "not related" to epicel by the reporter, it will be considered causally relate", this event is considered as related to epicel grafts. See scanned page.
Patient Sequence No: 1, Text Type: D, B5
[62390368]
Follow-up information was received on november 12, 2015 from a health care professional. The patient's race and ethnicity were reported as white and non-hispanic. The patient's medical history included allergy to codeine. Additional details regarding concomitant medications were not available due to patient's critical condition. On (b)(6) 2015, at work the patient had 76 percent deep partial and majority of full thickness burns secondary to gas line explosion. The co-workers called the emergency medical service immediately. At 14. 35, upon arrival of emergency medical service the patient complained of difficulty in breathing. Upon examination, it was noted that the patient suffered 54 percent third degree thermal burns on entire head (posterior and anterior), neck (entire anterior and posterior circumference) chest, back, buttocks and bilateral arms and 18 percent second degree thermal burns on bilateral upper thighs and knees and first degree burns on anterior pelvic region. The patient was alert, oriented and he was able to recall all the events which lead to injuries. Upon physical examination pupils were normal and reactive motor reflexes were weak, however sensory reflexes were absent on left and right upper portion and it was normal on the left and right lower portion of the body. Glasgow coma scale score was 15 and oxygen saturation was at 97 percent on a non-rebreather mask. Electrocardiogram (ecg) revealed sinus tachycardia. At 14 44, the patient was treated with intravenous 2 mg etomidate and 80 mg rocuronium. At 14:46, the patent responded to the treatment and there we no spontaneous respiration or movements noted. At 14:47, an attempt was made to place an orotracheal intubation tube which was unsuccessful. At 14 48, respiration was supported via bag valve mask (bvm) with 15 1/min. At 14:49, orotracheal intubation tube was successfully placed. The placement was verified by auscultation, capnography, chest rise and direct visualization. At 14 51, the patient was administered with intravenous 2 mg midazolam and 80 mcg fentanyl. At 14 53, the patient was transferred to stretcher with assistance and he was secured at 14:55, the patient was transported via aircraft. At 15:01, an additional dose of intravenous 80 mcg fentanyl and 2 mg midazolam was administered. At 15:03, escharotomy of anterior chest was performed and patient was placed on ventilator. At 15. 20, the patient arrived in the emergency department. Upon arrival, the patient was found to have had 7 6% total body surface area deep partial and full thickness burns with majority being full thickness burns. Trauma scan was negative for other injuries. Fluid resuscitation was initiated, arterial and central venous access was obtained and he was taken to burn unit where chest wall, neck and bilateral upper and lower escharotomies were performed. The patient was critically injured and he had inhalation injury with severe upper airway edema. The patient's vital signs included heart rate at 154 beats per minute and blood pressure was at 114/74 mmhg. The patient underwent extensive coverage with allograft. There was prior evidence of angio invasive aspergillus infection and multiple gram-negative rods (gnr) burn infections. On (b)(6) 2015, the patient underwent fascial excision and cadaveric grafting with allograft on neck, trunk bilateral upper and lower extremities the patient had a prolonged complicated hospital course. On (b)(6) 2015, he developed hypoxemia. Chest x-ray revealed right lower lobe pneumonia and bronchoscopy was consistent with aspiration pneumonia. Additional laboratory results included white blood cell (wbc) at 1. 6 and absolute neutrophil count (anc) at 1. 3. The patient initially received vancomycin and zosyn which was later changed to cefepime when both bronchoalveolar lavage (bal) and blood cultures revealed serratia marcescens. The patient's status continued to deteriorate consistent with acute respiratory distress syndrome. Hence, the patient was on pressure regulated volume control ventilation with intermittent neuromuscular blockade. On (b)(6) 2015, the patient was taken to the operating room for the excision of burns on the neck, chest and abdomen with application of acellular xenograft. Tissue biopsies prior to the excision showed serratia and candida albicans and the antibiotics were broadened to meropenem and diflucan (fluconazole). On (b)(6) 2015, scattered area of the wounds showed fungus the patient was taken to the operating room for further debridement and placement of acellular xenograft on the trunk and bilateral upper extremities. His face and neck skin were excised and cadaver skin transplant was done. His antibiotic regimen was switched to ceftaroline, voriconazole and amphotericin. Both operative culture and pathology revealed invasive aspergillus. His wounds were placed in gentian violet and later it was placed in amphotericin and sulfamylon. Norepinephrine and vasopressin were intermittently administered to maintain his blood pressure. On (b)(6) 2015, the wound cultures showed varying numbers of pseudomonas, serratia and candida; ceftaroline was stopped and cefepime was begun. On (b)(6) 2015, the patient was taken for re-excision of his lower extremity burns with placement of acellular xenograft. On (b)(6) 2015, the patient underwent versajet debridement and acellular grafting of xenograft on left back upper and lower extremities. The patient's wound culture showed acceptable levels of bacteria without further aspergillus. Treatment with amphotericin was discontinued when the voriconazole level was therapeutic. On (b)(6) 2015, the patient had autograft placed to the chest and abdomen with cadaver overlay a biologic mesh was also placed as an underlay at the site of prior fascial closure which had reopened on (b)(6) 2015, he developed an ileus, computed tomography (ct) revealed pancreatitis and right upper quadrant ultrasound revealed sludge. Pancreatitis was mild and resolved with a slight change in the treatment medication from voriconazole tack to amphotericin. On (b)(6) 2015, he underwent excision and acellular xenograft was placed on right back upper and lower extremities, wound culture prior to the excision showed greater than 200,000 pseudomonas sensitive to cipro (ciprofloxacin). Cefepime was changed to cipro. On (b)(6) 2015, the patient had an autograft placed with an onlay of cultured epidermal autografts to bilateral upper extremities and neck. On (b)(6) 2015, wound culture showed low colony counts of pseudomonas everywhere except for the left hip the patient remained on amphotericin, vancomycin, polymixin and gentamycin soaks. On (b)(6) 2015, autografts were used on the patient's face by plastic surgery. On (b)(6) 2015, systemic antibiotics were stopped and he remained on voriconazole. All autografts as well as the cultured epidermal autografts were adherent with minimal drainage from all the areas. His interstices were healing. On (b)(6) 2015, the patient had increased pressor requirements with noted increased pseudomonas type drainage from the back. Based on prior sensitivities, the gentamycin soaks were switched to tobramycin and meropenem was started. Blood cultures were positive for pseudomonas, sensitive to meropenem. Further debridement on the back was planned, however, his pulmonary status had significantly deteriorated making him unstable. The patient's back was soaked in dakin's solution (sodium hydrochloride) in addition to this he received intravenous amikacin. The patient continued to experience the worsening of multisystem organ failure. At the same time, an acute respiratory distress syndrome progressed requiring 90 - 100 percent fio2, neuromuscular blockade and flolan. The patient was not in a condition to undergo any surgery as any small movement would trigger bradycardia and asystole. On (b)(6) 2015, repeat blood cultures were negative and wound culture from back showed 4-8, 000 cfu pseudomonas with increasing resistance on (b)(6) 2015 at 3. 25, laboratory results included white blood cell (wbc) count at 19. 6, hemoglobin (hgb) 8. 4, hematocrit (hct) 27. 1, platelet (plt) 82, sodium (na) 140, chloride (cl) 110, blood urea nitrogen (bun) 83, potassium (k), 6. 5, bicarbonate (hco3) 25, creatinine 1. 23, glucose 188, abg with ph 7. 29, partial pressure of carbon dioxide (pco2) 45, partial pressure of oxygen (po2), bicarbonate (hc03) 22, blood glucose level was high. Chest x-ray revealed extensive bilateral infiltrates and bilateral effusions with minimal secretion and thick mucus plugs mainly on the left bronchi. No distal purulence was noted. "faction" of inspired oxygen (fio2) was 100 percent. The patient continued to receive vecuronium and flolan 40 ng inhalation. The patient also received norepinephrine of 0. 16 for hypotension and vasodilation. It was noted that the patient's renal function worsened with increased potassium at 6. 5 and creatinine to 1. 23. Hence, the patient experienced worsening acute renal failure. In addition he also experienced worsening hyperkalemia. On (b)(6) 2015 at 5:05, laboratory results included wbc 22. 8, hgb 8. 3, hct 26. 2, plt 117, na 138, cl 107, bun 108, k 7. 1, hco 24, creatinine 1. 45, glucose 114, calcium (ca) 8 2, magnesium (mg) 2 9, phosphorous 5. 8. The patient was still on high level ventilator support with large gradient and high positive end-expiratory pressure (peep). The patient remained pressor dependent. It was noted that the patient experienced worsening acute renal failure with creatinine at 1 45 and potassium 7. 1. The patient was septic due to gram-negative rods infectious disease (gnr) despite treating him with meropenem. The last skin isolate showed progressive antimicrobial resistance. It was reported that the patient's wife denied the additional support devices including dialysis to the patient based on poor likely outcome and patient's prior stated wishes. Considering the request, the patient was withdrawn from life support and hence the patient died on (b)(6) 2015 at 12. 45. The preliminary cause of death was reported as 72 percent tbsa burn, gram negative bacteraemia and septic shock, acute renal failure. Autopsy was requested; however, autopsy authorization form was not completed. The reporter considers that the death of the patient was "not related" to epicel instead, the patient died due to multisystem failure related to overwhelming organ sepsis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226230-2015-00004 |
| MDR Report Key | 5152201 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-10-08 |
| Date of Report | 2015-09-08 |
| Date of Event | 2015-09-07 |
| Date Mfgr Received | 2015-09-08 |
| Date Added to Maude | 2015-10-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES GOODRICH |
| Manufacturer Street | 64 SIDNEY ST. |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal | 02139 |
| Manufacturer Phone | 7344184527 |
| Manufacturer G1 | VERICEL CORPORATION |
| Manufacturer Street | 64 SIDNEY ST. |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02139 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPICEL |
| Generic Name | CULTURED EPIDERMAL AUTOGRAFTS |
| Product Code | OCE |
| Date Received | 2015-10-08 |
| Model Number | AU201 |
| Lot Number | EE01947A |
| ID Number | SO102357 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERICEL CORPORATION |
| Manufacturer Address | CAMBRIDGE MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2015-10-08 |