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

Lot Number MP163601

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

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

Rti (b)(4) conducted a batch documentation review for serial id (b)(4) manufactured from lot mp163601. 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)(4) met all acceptance / inspection criteria prior to distribution. To date, rti (b)(4) has manufactured and distributed (b)(4) 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 (b)(4), a wholly subsidiary of rti surgical, received a complaint as part of the fortiva appear trial. The reported complaint indicated that on (b)(6) 2020, the patient underwent a nipple conserving inframammary left and right mastectomy. 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: 12724106
• MDR Text Key: 282343563
• Report Number: 3002924436-2021-00032
• 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
• Type of Report: Initial
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/30/2021
• Device Lot Number: MP163601
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 10/29/2021 Patient Sequence Number: 1