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

Lot Number PD1810001

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

Patient Problems Local Reaction (2035); Seroma (2069); Breast Discomfort/Pain (4504); Skin Inflammation/ Irritation (4545)

Event Date 05/22/2021

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 gmbh (tmi), a wholly subsidiary of rti, received a complaint as part of the fortiva appear trial.The reported complaint indicated that a patient underwent implnatation of a fortiva graft for breast reconstruction on an unknown date.On (b)(6) 2020 the patient developed a seroma.Additional information has been requested and not received to date.

Manufacturer Narrative

Rti germany conducted a batch documentation review for serial id (b)(6) manufactured from lot pd1810001.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 the lot without related complaints.The development of red breast syndrome is a well known phenomenon following breast reconstruction after mastectomy with fortiva graft implanted.However, red breast syndrome may also be triggered by a seroma, hematoma, infection, radiation, vascular insufficiency and hypersensitivity reactions to specific materials.The patient developed red breast syndrome approximately 10 months post-operatively.It is more plausible that the patient's adverse event was associated with a source or event extrinsic to the xenograft implant.

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 trial.The reported complaint indicated the patient underwent a nipple conserving inframammary left and right mastectomy on (b)(6) 2020.Five lymph nodes were removed from the right side.No lymph nodes were removed on the left side.The patient underwent a bilateral breast reconstruction with implantation of two fortiva grafts and two silicone implants.Three drains were placed.One drain was removed on (b)(6) 2020 and the other two drains were removed on (b)(6) 2020.On (b)(6) 2021, approximately 10 months post-operatively, the patient developed bilateral red breast syndrome, pain and bilateral seromas that resolved on (b)(6) 2021.She was treated with clindamycin 600mg on (b)(6) 2021.She underwent seroma punctures on (b)(6) 2021.The seromas resolved on (b)(6) 2021 with no residual effects.In early (b)(6) 2021, the patient received a covid vaccination.Her symptoms following the vaccination consisted of redness, swelling, pain in her breasts, restricted movement of her arms and pain in her limbs.On (b)(6) 2021, the patient was treated with paracetamol for 3-4 days.Her symptoms resolved with no residual effects.

• Brand Name: FORTIVA PORCINE DERMIS
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): TUTOGEN MEDICAL, GMBH; industriestrasse 6; neunkirchen am brand, deu 91077 ; GM 91077
• MDR Report Key: 11720423
• MDR Text Key: 255953566
• Report Number: 3002924436-2021-00009
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K142070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

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: 10/31/2021
• Device Lot Number: PD1810001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR