MAUDE Adverse Event Report: ACELL, INC. MICROMATRIX

Model Number	MM1000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted due to the reported hematoma that occurred during the initial placement of the acell device.During the surgery micromatrix was focused mainly on the exposed areas: bone, tendon and undermined areas; versajet was also used on the wound.The patient has an external fixture device on his leg and ongoing wound vac therapy.Acell has conducted testing on the clotting capabilities of acell materials, including micromatrix in both in vitro and in vivo models.In both models, the use of micromatrix shortened clotting times compared to the controls, indicating a hemostatic effect.A review of the manufacturing records for this lot identified no deviations in the production process that fall outside of specification.The device was manufactured and distributed sterile in compliance with fda, state and local laws and regulations and acell's operating procedures.
Event or Problem Description
On(b)(4) 1820, acell, inc.Became aware a patient experienced hematoma formation after application of acell devices on (b)(6) 2018 for an acute wound.The male patient was in a motorcycle accident about 4 weeks earlier where he incurred a large de-gloving injury with exposed bone and tendon on his left leg.Wound vac had been utilized for several weeks prior to the surgery on (b)(6) 2018.During the surgery micromatrix was focused mainly on the exposed areas: bone, tendon and undermined areas; versajet was also used on the wound.The patient has an external fixture device on his leg and ongoing wound vac therapy.
Event or Problem Description
On (b)(6) 2018, acell, inc.Became aware a patient experienced hematoma formation after application of acell devices on (b)(6) 2018 for an acute wound.The patient was in a motorcycle accident about 4 weeks earlier where he incurred a large de-gloving injury with exposed bone and tendon on his left leg.Wound vac had been utilized for several weeks prior to the surgery on (b)(6) 2018.During the surgery acell micromatrix was focused mainly on the exposed areas: bone, tendon and undermined areas; versajet was also used on the wound.The patient has an external fixture device on his leg and ongoing wound vac therapy.
Additional Manufacturer Narrative
This is a follow-up report for additional information that was received subsequent to the initial filing.Acell was notified on (b)(6) 2018 that the patient had been on a prophylactic dose of lovenox, a blood thinner, for about a month prior to initial placement of the acell device.The initial mdr was submitted due to the reported hematoma that occurred during the initial placement of the acell device.During the surgery micromatrix was focused mainly on the exposed areas: bone, tendon and undermined areas; versajet was also used on the wound.The patient has an external fixture device on his leg and ongoing wound vac therapy.Acell has conducted testing on the clotting capabilities of acell materials, including micromatrix in both in vitro and in vivo models.In both models, the use of micromatrix shortened clotting times compared to the controls, indicating a hemostatic effect.A review of the manufacturing records for this lot identified no deviations in the production process that fall outside of specification.The device was manufactured and distributed sterile in compliance with fda, state and local laws and regulations and acell's operating procedures.

• Brand Name: MICROMATRIX
• Common Device Name: MICROMATRIX
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• MDR Report Key: 7832457
• Report Number: 3005920706-2018-00013
• Device Sequence Number: 16535528
• Product Code: KGN
• UDI-Device Identifier: 00386190001202
• UDI-Public: (01)00386190001202(17)200331(10)012072
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: MM1000
• Device Catalogue Number: MM1000
• Device Lot Number: 012072
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXTERNAL FIXTURE DEVICE; LOVENOX; VERSAJET HYDROSURGERY SYSTEM; VERSAJET HYDROSURGERY SYSTEM; WOUND VAC THERAPY; WOUND VAC THERAPY; EXTERNAL FIXTURE DEVICE; VERSAJET HYDROSURGERY SYSTEM; WOUND VAC THERAPY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR