MAUDE Adverse Event Report: TUTOGEN MEDICAL, GMBH FORTIVA; PORCINE, DERMIS

Lot Number PD19360001

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Necrosis (1971); Seroma (2069); Impaired Healing (2378); Needle Stick/Puncture (2462)

Event Date 08/27/2021

Event Type  Injury  

Manufacturer Narrative

At this time, it is unknown if the graft remains implanted.A comprehensive records re-review is being conducted.Once the results are available, a follow-up report will be submitted.

Event Description

Rti surgical, inc.And tutogen medical gmbh (tmi), a wholly subsidiary of rti surgical, received a complaint as part of the fortiva appear study.The complaint indicated that the patient underwent a surgical procedure, on an unknown date, with implantation of an rti fortiva graft.On (b)(6) 2021, the patient developed bleeding.

Event Description

Additional information was provided to rti surgical inc.And tutogen medical gmbh (tmi), a wholly subsidiary of rti surgical which indicated that the patient is a 48-year-old female who underwent a bilateral breast reconstruction post mastectomy on (b)(6) /2021.Two fortiva® dermal grafts and two silicone implants were implanted.Three lymph nodes were removed on the left side.Three drains were placed; 1 drain on the right side and two drains on the left side.The following day, post-operatively, the patient experienced bleeding right mamma (not analogue to the seroma) which resolved.On (b)(6) 2021, the right drain and one of the left drains were removed.On (b)(6) 2021, the second left drain was removed.On (b)(6) 2021, the patient developed a seroma on both sides which were treated via aspiration.She also developed nipple-areola complex necrosis (the side was not specified).The necrosis was related to the procedure and not the graft.No treatment was administered.On (b)(6) 2021, the patient developed recurrent seromas on both sides that was also treated via aspiration.On (b)(6) 2021, the patient developed a wound healing disorder on the right side and was admitted to the hospital.The following day, she underwent necrosis ablation, skin envelope tightening, and implant exchange for the expander.On (b)(6) 2021, the patient was discharged from the hospital.Her event was related to the procedure and not the graft.On (b)(6) 2021, the patient developed another recurrent seroma (the side was not specified) that was treated via aspiration.To date, no additional information has been provided.

Manufacturer Narrative

Rti germany conducted a batch documentation review for serial id (b)(6) manufactured from lot pd19360001.Two departures from standard operating procedures were noted during the records re-review (temperature exceedance fridge no.952 & missing ozonisation records hpw-system) that would not negatively impact the manufacturing of porcine dermal xenografts from the lot.Manufacturing records review indicated that serial id (b)(6) met all acceptance / inspection criteria prior to distribution.To date, rti germany has manufactured and distributed nine fortiva® dermal grafts from lot pd19360001 without related complaints.Bleeding atter a surgery is a common post-operative complication.For this complaint, the bleeding and procedure occurred on the same day.Based on the additional information that was provided, the patient's post-operative bleeding was exclusively related to the surgical procedure and not with the fortiva® xenograft.Development of a seroma is a common post-operative complication.Additionally, seroma development may be the result of the patient having poor wound healing, high activity level post-operatively, the surgical procedure itself or by an implant that influences wound healing (e.G.The silicone implants).After a mastectomy with immediate reconstruction, sometimes the breast skin doesn't heal properly.If there isn't enough blood flow to the skin, the skin can wither and scab which causes necrosis.In general, problems in wound healing can be associated with, e.G.Injuries, surgeries, failure of blood supply to the surgical site, infection or radiation therapy.Investigation results indicate it is more plausible that the patient's adverse event is associated with a source or event extrinsic to the fortiva® dermal xenograft.

• Brand Name: FORTIVA
• Type of Device: PORCINE, DERMIS
• Manufacturer (Section D): TUTOGEN MEDICAL, GMBH; industriestrasse 6; neunkirchen am brand; deu, germany 91077 ; GM 91077
• Manufacturer (Section G): RTI SURGICAL, INC; 11621 research circle; alachua FL 32615
• Manufacturer Contact: karen britt ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 12658554
• MDR Text Key: 277208134
• Report Number: 3002924436-2021-00027
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/31/2024
• Device Lot Number: PD19360001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Female