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

Lot Number PD17210001

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

Patient Problems Breast Cancer (1759); Necrosis (1971); Seroma (2069)

Event Date 08/15/2019

Event Type  Injury  

Manufacturer Narrative

The implant was not returned for evaluation.Therefore, a comprehensive records re-review was conducted.There were no departures noted that would negatively impact the xenograft implants manufactured from lot pd17210001.Manufacturing records review indicated that serial id (b)(4) met all specifications and release criteria prior to distribution.Rti/tmi has manufactured and distributed a total of 24 xenograft implants from the lot without related complaints.Porcine dermis xenograft implants udnergo a validated sterilization method: tutoplast®, which includes terminal sterilization by gamma irradiation after packaging.To date, our investigation indicates that the reported complications are more likely associated with one or more extrinsic factors, rather than an intrinsic property of fortiva porcine dermis xenograft.

Event Description

Rti surgical, inc (rti) and tutogen medical (b)(4))tmi, a wholly owned subsidiary of rti, received a complaint which indicated that a patient, enrolled in the fortiva appear trial, underwent nipple sparing mastectomy of the left breast with implantation of a fortiva perforated porcine dermis graft and a silicone breast implant on (b)(6) 2019.The patient received antibiotics during surgery and two drains were left in place in the axila.On (b)(6) 2019, she developed necrosis of the left breast bar area which was considered to be procedure related and not related to the fortiva implant.The drains were removed on (b)(6) 2019 and the patient was discharged.On (b)(6) 2019, the patient underwent necrosis ablation and on (b)(6) 2019, a third of the fortiva graft was removed.Upon follow up on (b)(6) 2019, good wound healing was noted.A seroma was seen on ultrasound which was drained, revealing a serous fluid.The patient is doing well.To date, no additional information has been received.

• Brand Name: FORTIVA PERFORATED DERMIS
• Type of Device: PORCINE DERMIS
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestrabe; neunkirchen am brand 97077 ; GM 97077
• Manufacturer Contact: leila kelly ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 9365162
• MDR Text Key: 185489691
• Report Number: 3002924436-2019-00012
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/31/2021
• Device Lot Number: PD17210001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other