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

Lot Number PD18100001

Device Problem Insufficient Information (3190)

Patient Problems Necrosis (1971); Local Reaction (2035); Seroma (2069)

Event Date 08/20/2020

Event Type  Injury  

Manufacturer Narrative

Unique identifiers were not provided in order to conduct a comprehensive records re-review.If additional information becomes available, a follow up report will be submitted.

Event Description

Rti surgical, inc (rti) and tutogen medical (b)(4) (tmi), a wholly subsidiary of rti, received a complaint as part of the fortiva appear trial.The reported complaint indicated that a patient was implanted with a fortiva porcine dermis on an unknown date.On (b)(6) 2020, the patient developed skin necrosis.Additional information has been requested and not received to date.

Event Description

Additional information was provided which indicated that the patient underwent removal of two lymph nodes on the right side and a bilateral breast reconstruction with implantation of a fortiva graft on (b)(6) 2020.Two silicone implants were also placed and three drains remained indwelling.On (b)(6) 2020, the first drain was removed.On (b)(6) 2020, the second and third drains were removed.(b)(6) 2020, the patient developed two major seromas.Over a timeframe of 19 days, the patient underwent five aspirations of both seromas which resolved on (b)(6) 2020.

Manufacturer Narrative

Rti germany conducted a batch documentation review for serial id (b)(6) manufactured from lot pd18100001.No departures from standard operating procedures were noted during the records re-review that would negatively impact the manufacturing of porcine dermis 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 51 fortiva dermis grafts from lot pd18100001.There are 7 related complaints associated with the lot and the fortiva appear trial.Seroma formation may also be caused by decreased blood supply at the surgical site, poor soft tissue coverage, weight, infection, poor glycemic control, medications, physical location of the surgical site, and cumulative risk factors increase the likelihood of complications.Often drains are placed during a surgery to prevent seroma formation.In this specific case, drains had been placed on both sides and wound secretion had been documented on both sides.Nevertheless, a major seroma developed on both sides.Seroma formation has frequently been reported to occur post-operatively, especially when lymphatic vessels have been cut.It is more plausible that the patient's adverse event was associated with a source or event extrinsic to the xenograft implant.

• Brand Name: FORTIVA PORCINE DERMIS
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestrabe 6; neunkirchen am brand, 91077 ; GM 91077
• Manufacturer Contact: karen britt ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 11720639
• MDR Text Key: 250271150
• Report Number: 3002924436-2021-00011
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Lot Number: PD18100001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Female