MAUDE Adverse Event Report: TUTOGEN MEDICAL, GMBH TUTOPATCH® BOVINE PERICARDIUM

Device Problems Material Twisted/Bent (2981); Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Necrosis (1971); Seroma (2069); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Rti surgical, inc.And tutogen medical gmbh (tmi), a wholly subsidiary of rti surgical, received a complaint on 11/23/2023, resulting from a literature review.The article was published in the journal of springer nature and international society of aesthetic plastic surgery 2023 titled, " implant-based breast reconstruction with bovine pericardium: our approach using tutopatch® and review of literature".Of note, no unique serial ids of the tutopatch® grafts that were utilized in the study were documented in the article.Per the instructions for use (ifu), tutopatch® grafts are supposed to be used for dura replacement for craniotomy procedures.The article stated that 103 patients (comprising 114 breasts) underwent immediate implant-based breast reconstructions using bovine pericardium bovine matrix.The procedures were performed by the same surgical team between april 2018 and may 2023.Tutopatch® bovine pericardium grafts were implanted for the breast reconstructions.Post-operative complications were categorized into early and late complications.For early complications (within the first 60 days), the following factors were considered: ischemia of mastectomy flaps, skin necrosis (minor if partial thickness, requiring conservative treatments; major if full thickness, necessitating surgical revision), bleeding, hematoma formations, wound dehiscence.Results indicated that one patient developed wound dehiscence.One patient developed an infection.Four patients developed flap ischemia (spontaneous resolution).One patient developed skin necrosis.One patient developed bleeding.Two patients developed a hematoma.The late post-operative complications (after 60 days), consisted of seroma formation, presence of rippling, animation deformity, capsular contracture, wound dehiscence, and implant rotation.Results indicated that one patient developed wound dehiscence.Eight patients developed a seroma.Two patients developed rippling.Two patients developed animation deformity.One patient developed capsular contracture.One patient developed rotation of the implant.In conclusion, the preserving material characteristics of the tutopatch® graft effectively resist tensile forces during soft tissue repair was of utmost importance.Tutopatch® bovine pericardium grafts stood out as a promising option in this regard.Studies have demonstrated that tutopatch® bovine pericardium grafts retain the native multi-directional network of collagen fibers, which is vital for optimal tissue repair.Tutopatch® bovine pericardium has revealed significantly higher values for uniaxial max load, ultimate tensile strength (uts), and modulus.These findings indicate that tutopatch® exhibits superior mechanical properties, making it well-suited for applications where durability and resilience are essential for successful outcomes in soft tissue repairs.Tutopatch® grafts demonstrates considerable advantages as a biomaterial for breast reconstruction, rendering it an appealing choice in clinical practice.The efficacy of tutopatch® in breast reconstruction has been demonstrated, and its adoption as an alternative to conventional methods holds promise.Based on accumulated clinical experience, tutopatch® grafts can be regarded as a safe and effective biomaterial for breast reconstruction.To date, no additional information has been provided to rti for review.

Manufacturer Narrative

Rti germany's investigation is in process.Once the results are available, a follow-up report will be submitted.

• Brand Name: TUTOPATCH® BOVINE PERICARDIUM
• Type of Device: TUTOPATCH®
• Manufacturer (Section D): TUTOGEN MEDICAL, GMBH; industriestrasse 6; neunkirchen am brand, deu 91077 ; GM 91077
• Manufacturer Contact: karen britt ; 11621 research circle; alachua, FL 32615 ; 3865186607
• MDR Report Key: 18356052
• MDR Text Key: 330886732
• Report Number: 3002924436-2023-00006
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: No
• 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