MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-02-03 for EPICEL AU201 manufactured by Vericel Corporation.
[66487027]
40 grafts; sales order number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[66487028]
This spontaneous report was received from an healthcare professional via a sales representative on (b)(6) 2017, concerning an (b)(6) male patient weighing (b)(6) with height (b)(6) who expired after being grafted with epicel cultured epidermal autografts (epicel). The patient was grafted with 40 units of epicel with lot number ee02114 for full thickness burns. Details regarding medical history was not provided and concomitant medication reported included vashe (topical antifungal), ancef (cefazolin sodium) and zosyn (piperacillin sodium, tazobactam sodium) as systemic antifungal. Allergies were ruled out to vancomycin, amikacin and amphotericin b. No other significant dermatological history reported. On (b)(6) 2016, the patient was injured and hospitalized. On (b)(6) 2016, a biopsy was performed on right groin and right axilla. No wound or systemic infection of microbial and fungal origin were reported. On (b)(6) 2016, the patient underwent surgery and was grafted with 40 units of cultured epidermal autografts with lot number ee02114, product part number au201 and sales order number (b)(4). On an unspecified date after the graft, the patient expired from an unknown cause. Details regarding treatment was not provided. Further details including description of clinical presentation, signs, symptoms, diagnostic tests, 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. The company considers the death as possibly related to epicel in the absence of any other information regarding the cause of death and based on the conditions of the humanitarian device exemption.
Patient Sequence No: 1, Text Type: D, B5
[69221027]
Forty grafts; sales order number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[69221028]
This spontaneous report was received from an healthcare professional via a sales representative on 04-jan-2017, concerning an (b)(6) male patient weighing (b)(6) with height (b)(6) who expired after being grafted with epicel cultured epidermal autografts (epicel). The patient was grafted with 40 units of epicel with lot number ee02114 for full thickness burns. Details regarding medical history was not provided and concomitant medication reported included vashe (topical antifungal), ancef (cefazolin sodium) and zosyn (piperacillin sodium, tazobactam sodium) as systemic antifungal. Allergies were ruled out to vancomycin, amikacin and amphotericin b. No other significant dermatological history reported. On (b)(6) 2016, the patient was injured and hospitalized. On (b)(6) 2016, a biopsy was performed on right groin and right axilla. No wound or systemic infection of microbial and fungal origin were reported. On (b)(6) 2016, the patient underwent surgery and was grafted with 40 units of cultured epidermal autografts with lot number ee02114, product part number au201 and sales order number (b)(4). On an unspecified date after the graft, the patient expired from an unknown cause. Details regarding treatment was not provided. Further details including description of clinical presentation, signs, symptoms, diagnostic tests, 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. The company considers the death as possibly related to epicel in the absence of any other information regarding the cause of death and based on the conditions of the humanitarian device exemption. Additional information was received on 31-jan-2017 from a staff nurse. The nurse reported that the patient was on comfort care measures prior to death and expired on (b)(6) 2016. The cause of death was reported as multi system organ failure. Qc sterility test results of pre-release sample type from 10-dec-2016 to 24-dec-2016 and of final product sample type from 14-dec-2016 to 28-dec-2016 were both negative. Environmental results: personnel monitoring of manufacturing passed in grade a and b parameters and personnel monitoring of qc sterility passed with grade a parameters. On 14-dec-2016, the quality control assay were reviewed which included qc2-027 graft inspection (40 grafts available for shipment), qc2-094 dual stain (50-75%) and qc2-010 endotoxin (<1%) as passed. The reporter did not provide the causal relationship between the event and epicel grafts. The company considers the death as not related to epicel as the multi system organ failure could be the clinical course following extensive injury and surgery with multiple grafts. Further details about the course of the patient's hospitalization leading to multiorgan failure is awaited. No new additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[70648667]
Case description: this spontaneous report was received from an healthcare professional via a sales representative on 04-jan-2017, concerning an (b)(6) male patient (b)(6) who expired after being grafted with epicel cultured epidermal autografts (epicel). The patient was grafted with 40 units of epicel with lot number ee02114 for full thickness burns. Details regarding medical history was not provided and concomitant medication reported included vashe (topical antifungal), ancef (cefazolin sodium) and zosyn (piperacillin sodium, tazobactam sodium) as systemic antifungal. Allergies were ruled out to vancomycin, amikacin and amphotericin b. No other significant dermatological history reported. On (b)(6) 2016, the patient was injured and hospitalized. On (b)(6) 2016, a biopsy was performed on right groin and right axilla. No wound or systemic infection of microbial and fungal origin were reported. On (b)(6) 2016, the patient underwent surgery and was grafted with 40 units of cultured epidermal autografts with lot number ee02114, product part number au201 and sales order (b)(4). On an unspecified date after the graft, the patient expired from an unknown cause. Details regarding treatment was not provided. Further details including description of clinical presentation, signs, symptoms, diagnostic tests, 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. The company considers the death as possibly related to epicel in the absence of any other information regarding the cause of death and based on the conditions of the humanitarian device exemption. Additional information was received on 31-jan-2017 from a staff nurse. The nurse reported that the patient was on comfort care measures prior to death and expired on (b)(6) 2016. The cause of death was reported as multi system organ failure. Qc sterility test results of pre-release sample type from (b)(6) 2016 and of final product sample type from (b)(6) 2016 were both negative. Environmental results: personnel monitoring of manufacturing passed in grade a and b parameters and personnel monitoring of qc sterility passed with grade a parameters. On (b)(6) 2016, the quality control assay were reviewed which included qc2-027 graft inspection (40 grafts available for shipment), qc2-094 dual stain (50-75%) and qc2-010 endotoxin (<1%) as passed. The reporter did not provide the causal relationship between the event and epicel grafts. The company considers the death as not related to epicel as the multi system organ failure could be the clinical course following extensive injury and surgery with multiple grafts. Further details about the course of the patient's hospitalization leading to multiorgan failure is awaited. No new additional information was provided. Additional information was received on 03-mar-2017: the additional environmental tests performed on (b)(6) 2017 for the personnel monitoring of manufacturing included viable air particulates and sleeve plate test which showed passed results in grade a except for scp ( dispaser ) the organism was a gram - rod; id - chryseobacterium taklimakanese. Additional tests for the personnel monitoring of qc sterility included sleeve plate test which also showed passed results with grade a parameters. No new additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226230-2017-00001 |
| MDR Report Key | 6300599 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-02-03 |
| Date of Report | 2017-04-01 |
| Date of Event | 2016-11-14 |
| Report Date | 2017-03-03 |
| Date Reported to Mfgr | 2017-03-03 |
| Date Mfgr Received | 2017-03-03 |
| Date Added to Maude | 2017-02-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LIZ GREKAS |
| Manufacturer Street | 64 SIDNEY STREET |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal | 02139 |
| Manufacturer G1 | VERICEL CORPORATION |
| 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 | 3 |
| Brand Name | EPICEL |
| Generic Name | EPICEL |
| Product Code | MGQ |
| Date Received | 2017-02-03 |
| Model Number | AU201 |
| Lot Number | EE02114 |
| Device Expiration Date | 2017-03-30 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Hospitalization | 2017-02-03 |