MAUDE Adverse Event Report: VERICEL CORPORATION EPICEL

Model Number AU201

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/14/2016

Event Type  Death  

Manufacturer Narrative

40 grafts; sales order number (b)(4).

Event Description

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.

Manufacturer Narrative

Forty grafts; sales order number (b)(4).

Event Description

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.

Event Description

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.

• Brand Name: EPICEL
• Type of Device: EPICEL
• Manufacturer (Section D): VERICEL CORPORATION; 64 sidney street; cambridge MA 02139
• Manufacturer (Section G): VERICEL CORPORATION; 64 sidney street; cambridge MA 02139
• Manufacturer Contact: liz grekas ; 64 sidney street; cambridge, MA 02139
• MDR Report Key: 6300599
• MDR Text Key: 66487027
• Report Number: 1226230-2017-00001
• Device Sequence Number: 1
• Product Code: MGQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: HDE 99002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2017,04/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/30/2017
• Device Model Number: AU201
• Device Lot Number: EE02114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Report to Manufacturer: 03/03/2017
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ANCEF /(B)(4)/ (CEFAZOLIN SODIUM); ANTIFUNGALS FOR DERMATOLOGICAL USE; ZOSYN (PIPERACILLIN SODIUM, TAZOBACTAM SODIUM)
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 86 YR
• Patient Weight: 78