MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2017-07-18 for EPICEL AU201 manufactured by Vericel Corporation.
[80379759]
Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[80379760]
Passed away [death]. Case description: this spontaneous report was received from a sales representative on (b)(6) 2017, concerning a (b)(6) year-old male patient, who expired on (b)(6) 2017, 44 days after grafting with epicel cultured epidermal autografts (epicel). The patient was grafted with unknown units of epicel, lot number ee02178, for thermal burn. The relevant medical history and concomitant medication details were not reported. On (b)(6) 2017, a (b)(6) year old male patient was injured with 95% total body surface area burn (tbsa) and was admitted to the hospital. On (b)(6) 2017, biopsy was taken from right axilla and suprapubic area. The patient received silvadene (silver sulfadiazine) as a treatment. On (b)(6) 2017, epicel grafts were applied to bilateral circumferential legs. The product part number was reported as au201 and sales order number was (b)(6). The quantity affected was reported as (b)(6). On (b)(6) 2017, 44 days after grafting with epicel, the patient expired. The product was not returned to the manufacturer. Autopsy details were not provided. Therapeutic measures were not provided. The reporter's causality between the event and epicel grafts was not reported. Based on limited information the company assessed as related to epicel. The causality will be reassessed on receipt of follow up information.
Patient Sequence No: 1, Text Type: D, B5
[92965042]
This spontaneous report was received from a sales representative on (b)(4) 2017, concerning a (b)(6) -year-old male patient, who expired on (b)(6) 2017, 44 days after grafting with epicel (cultured epidermal autografts). The patient was grafted with 96 units of epicel, lot number ee02178, for thermal burn. Relevant medical history and concomitant medication details were not reported. On (b)(6) 2017, the patient was injured with 95% total body surface area burn (tbsa) and was admitted to the hospital. On (b)(6) 2017, a biopsy was taken from right axilla and suprapubic area. The patient received silvadene (silver sulfadiazine) as treatment. On (b)(6) 2017, epicel grafts were applied to bilateral circumferential legs. The product part number was reported as au201 and sales order number was (b)(4). The quantity affected was reported as 96. On (b)(6) 2017, 44 days after grafting with epicel, the patient expired. The product was not returned to the manufacturer. Autopsy details were not provided. Therapeutic measures were not provided. The reporter's causality between the event and epicel grafts was not reported. Based on limited information the company assessed as possibly related to epicel. The causality will be reassessed on receipt of follow up information. Additional information was received on (b)(6) 2017 via a physician and resulted in reporting of the events: heart rate dropped to 30s and then finally to 0 (heart rate decreased), liver failure (hepatic failure), kidney failure (renal failure), hypotension (hypotension) , multiple organ dysfunctional syndrome ( multiorgan failure), wound sepsis, atrial flutter, mental status declined (mental status changes), and patient is not giving any responses, not had any gag responses and lying in bed motionless (unresponsive to stimuli). It was reported that the patient was a (b)(6) -year-old male who had been hospitalised for 52 days, following severe burns with 90% surface burns. Past medical history included hypertension and a current condition of thermal burns. The current medication included atenolol, human albumin, albuterol (salbutamol), amiodarone, ascorbic acid, calcium gluconate, cefepime, ddavp (desmopressin acetate), fentanyl, epinephrine, dopamine, gentamicin cream, hydrocortisone cream, insulin drip, topical solution, versed (midazolam hydrochloride), multivitamin, nystatin cream, norepinephrine, pantoprazole, senna (senna alexandrina), colistin , tobramycin and vasopressin. During the hospitalization , the patient had bronchospasm and was on ventilator and later tracheostomy was performed. The patient had multiple procedures to debride the wounds and close the wounds. On (b)(6) 2017, colistin was added as the wound culture showed treatment resistant pseudomonas aeroginosa. Over a period of stay, the patient had developed acute kidney injury with hyperkalemia refractory to medical therapy and gradually became anuric. On-(b)(6) 2017 the patient became hemodynamically unstable. By (b)(6) 2017, the patient was on four pressors, had acidosis and developed acute liver failure. The patient had required sedation throughout his stay. The sedation was subsequently stopped on an unspecified date. It was reported that the patient was in atrial flutter and required to be shocked to get him into tachycardia. Following resuscitation, the patient's mental status declined. Initially he was sedated, but he was responsive to pain and was withdrawing arms. In the last 24-48 hours, the patient was not giving any responses. He had not had any gag responses in the last 24 hours. Neurology was therefore called to evaluate for lack of responsive, despite sedation being discontinued over the past 24 hours. The patient was on ventilator and was intubated, with tracheostomy and also received tube feedings via percutaneous endoscopic gastrostomy (peg) tube. He was currently lying in bed motionless. It was reported that most of the patient head had wounds that were dressed; however, the face was visible with some scars. He had tarsorrhaphy and only little bit of the cornea was seen. Breath sounds were heard bilaterally. Heart sounds were hardly audible. Physical exam was limited because the patient was in bandage all over the body from the toes and fingers and hands and feet up to the trunk, up to the neck. There was no response to forehead pressure. There was no response to chest pressure. There was no response to nail bed pressure in the fingers or toes. The patient's complete blood count (cbc) showed white blood cells (wbc) of 14. 2, red blood cells (rbc) 1. 49, hemoglobin 4. 4, hematocrit 16. 6, mean corpuscular volume (mcv) 111. 4, mean corpuscular hemoglobin (mch) 29. 7, mchc 26. 7, row 17. 3, and platelet count of 69,000. Absolute lymphocyte count is 0. 09. Coagulation showed a pt of 32. 7, inr 3. 3 and ptt of 40. Chemistry showed sodium of 156, potassium 5. 5, chloride 102, bicarbonate was very low, glucose was 106. Bun 47 and creatinine was 1. 7. Calcium is 7. 8, magnesium 3. 6, phosphorus 16. 1, total serum protein 5. 2, albumin 2. 2, bilirubin 1. 1, alkaline phosphatase 349, ast 2584, alt 37, and lactic acid this morning was 34. 8. As per the neurology consultation, the patient had severe encephalopathy, which was multifactorial. It was due to multiple metabolic abnormalities as indicated by his grossly abnormal metabolic profile. It was also possible that the patient had suffered a massive stroke. This was because the final severe decline in mental state, when the patient became totally unresponsive. Following the resuscitation for atrial flutter, at which point the patient would require to be shocked couple of times. Also looking at the trend of blood pressures or since admission, the records showed blood pressures are fairly low. He, therefore, may had significant cardiomyopathy and significant risk of cardiac thrombus that can lead to masking or cardio embolic infarcts. This could account for a sudden recent decline in mental status due to his state of total unresponsiveness. Also, with a prolonged sedation that was required since admission for about 50 days, would have cumulative effect. Over 90% of surface body burns. The patient had poor cardiac function which was indicated by several episodes of very low blood pressures since admission. On (b)(6) 2017, patient condition further deteriorated it was also reported that the patient's heart rate dropped to 30's and atropine was administered however, then the heart rate finally was reduced to zero with no pulse. The patient passed away on the same day. Qc sterility test results of pre-release sample type from (b)(6) 2017 for the "deviation (b)(4)" was not provided. The qc sterility test results of pre-release sample type from (b)(6) 2017 and final product sample from (b)(6) 2017 were both negative. Environmental results included personnel monitoring of manufacturing which had passed with grade a and b parameters and personnel monitoring of qc sterility passed in grade a parameters. The quality control assay was reviewed which included (b)(4) graft inspection (results were 96 grafts available for shipment interpretation was pass) and (b)(4) dual stain assay (results: 75-100 percent) and (b)(4) endotoxin assay as passed (result: <1 eu/ml). The outcome of the events was not provided. Action taken with epicel was not applicable. The causality for the events was not reported by the reporter. The company assessed the events of heart rate decreased, hepatic failure, renal failure, hypotension, multiple organ dysfunctional syndrome wound sepsis, atrial flutter, mental status changes, and patient unresponsive to stimuli as not related to epicel. Sepsis, multi organ failure and metabolic abnormalities are other possible alternative explanations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226230-2017-00006 |
| MDR Report Key | 6723809 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2017-07-18 |
| Date of Report | 2017-06-23 |
| Date of Event | 2017-06-22 |
| Date Mfgr Received | 2017-07-17 |
| Date Added to Maude | 2017-07-18 |
| 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 | MS. LIZ GREKAS |
| Manufacturer Street | 64 SIDNEY STREET |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal | 02139 |
| Manufacturer G1 | LIZ GREKAS |
| Manufacturer Street | 64 SIDNEY STREET |
| 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 | 0 |
| Brand Name | EPICEL |
| Generic Name | CULTURED EPIDERMAL AUTOGRAFTS |
| Product Code | OCE |
| Date Received | 2017-07-18 |
| Model Number | AU201 |
| Lot Number | EE02178 |
| Device Expiration Date | 2017-12-07 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERICEL CORPORATION |
| Manufacturer Address | 64 SIDNEY STREET CAMBRIDGE, MA 02139 US 02139 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2017-07-18 |