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

Lot Number PD18440001

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

Patient Problems Breast Cancer (1759); Post Operative Wound Infection (2446)

Event Date 09/26/2021

Event Type  Injury  

Manufacturer Narrative

The fortiva porcine dermis graft remains implanted.Therefore, a comprehensive records re-review was conducted.There were no departures noted during records re-review that would negatively impact the manufacturing of xenografts from lot pd18440001.Manufacturing records indicated that serial id (b)(4) met all specifications and release criteria prior to distribution.There are no related complaints associated with the lot.Porcine dermis xenografts undergo a validated sterilization method: tutoplast®, which includes terminal sterilization by gamma irradiation after packaging.The reported post operative infection 20 months after the implantation of the fortiva graft.In this timeline, the graft should have been totally integrated.Therefore, it is most likely that the reported post operative complications are associated with a source or event extrinsic to the fortiva graft.To date, our investigation indicates that the reported complications are more likely associated with one or more extrinsic factors, rather than in intrinsic property of the fortiva porcine dermis xenograft.

Event Description

Rti surgical, inc (rti) and tutogen medical gmbh (tmi), a wholly subsidiary of rti, received an adverse event complaint on (b)(6) 2022 as part of the fortiva appear clinical trial.The reported complaint indicated that a 47 years old female patient with history of stage iiia breast cancer underwent a left nipple removing skin sparing mastectomy.On (b)(6) 2020, the patient underwent a left breast reconstruction with implantation of a fortiva porcine dermis graft and a silicone implant.Eleven lymph nodes were removed.Two drains were placed, one on the left chest wall (removed on (b)(6) 2020) and one on the left axilla (removed on (b)(6) 2020).The patient was discharged from the hospital on (b)(6) 2020 with analgesics, nonsteroidal anti-inflammatory medication, omeprazole and sennoside.On (b)(6) 2021, the patient was prescribed flucloxacillin for the wound on the left breast.She was diagnosed with an infection of the left breast on (b)(6) 2021 requiring antibiotics and immediate silicone implant removal.Follow up reported on (b)(6) 2021 indicated that the infection had resolved with residual effects (not specified).To date, additional information has not been provided.

• Brand Name: FORTIVA PORCINE DERMIS
• Type of Device: PORCINE DERMIS
• Manufacturer (Section D): TUTOGEN MEDICAL, GMBH; industriestrabe 6; neunkirchen am brand 91077 ; GM 91077
• Manufacturer Contact: leila kelly ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 15089013
• MDR Text Key: 296464383
• Report Number: 3002924436-2022-00010
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Lot Number: PD18440001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female