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

Lot Number PD18100001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Necrosis (1971); Impaired Healing (2378)

Event Date 10/30/2020

Event Type  Injury  

Manufacturer Narrative

Unique identifiers have not been 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 on 02/17/2021, as part of the fortiva appear trial.The reported complaint indicated that a patient underwent implantation of a fortiva porcine dermis for breast reconstruction on an unknown date.On (b)(6) 2020 the patient developed skin necrosis.To date, the additional information requested has not been received.

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 (b)(4) fortiva dermis grafts from the lot without related complaints.In general, problems in wound healing can have many causes, e.G.Injuries, surgeries, failure of blood supply to the site, infection or radiation therapy.The patient was a current smoker which may have influenced blood flow and capillary vessel lumen in the skin at the implantation site.Further, the surgery, silicone implants were placed as well on both sides that were considered further confounding factors.It is more plausible that the patient's adverse event was associated with a source or event extrinsic to the xenograft implants.

Event Description

On (b)(6)2020, the patient underwent a bilateral breast reconstruction with implantation of two fortiva grafts and placement of two expanders.The patient had 11 lymph nodes removed on the right side and 9 lymph nodes removed on the left.On (b)(6)2020, the patient experienced delayed wound healing.The patient was hospitalized (b)(6)2020 to (b)(6)2020.The issue resolved on (b)(6)2020.The cutaneous necrosis from the vertical scar was conservatively treated; the seam dehiscence and the edges of the wound were refreshed.This report is also associated with mfr report #: 3002924436-2021-00034.

• Brand Name: FORTIVA
• Type of Device: PORCINE DERMIS
• Manufacturer (Section D): TUTOGEN MEDICAL, GMBH; industriestrasse 6; neunkirchen am brand, deu 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: 11527978
• MDR Text Key: 241033177
• Report Number: 3002924436-2021-00007
• 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: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Lot Number: PD18100001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2018
• 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 Sex: Female