MAUDE Adverse Event Report: RTI SURGICAL, INC. FORTIVA PORCINE DERMIS; SURGICAL MESH

Lot Number MP150701

Device Problems Degraded (1153); Material Protrusion/Extrusion (2979)

Patient Problems Wound Dehiscence (1154); Breast Cancer (1759); Unspecified Infection (1930)

Event Date 06/17/2016

Event Type  Injury  

Manufacturer Narrative

Method: the xenograft was not returned to rti for evaluation.A re-review of the manufacturing and internal records, sterilization run reports, environmental monitoring results, quality control/assurance review and release, and review of the complaints database for related complaints associated with the lot were performed.Results: no deviations were noted during processing for lot# mp150701 that affected the release of serial id (b)(4).The graft underwent a validated sterilization methodology; tutoplast which includes terminal sterilization by gamma irradiation after packaging.To date, (b)(4) has distributed (b)(4) fortiva dermis grafts from the lot without related complaints.Environmental data and records generated during and around the time of processing was acceptable.Conclusion: no deviations were noted in the records re-review that negatively impacted dermis grafts manufactured from lot# mp150701.Serial (b)(4) was manufactured to specifications and met all requirements and release criteria at the time of distribution.There are no related complaints associated with dermis grafts distributed from the lot.Based on the records re-review and the information provided, this event is unlikely related to the xenograft implant.Sent for pathology at hospital.

Event Description

(b)(4) and tutogen medical (b)(4), a wholly owned subsidiary of (b)(4) received a complaint on 07/06/2016 indicating the patient is a (b)(6) female who underwent a nipple-sparing mastectomy with a primary reconstruction after recurrence of a left ductal carcinoma on (b)(6) 2016 with a fortiva dermis graft and breast implant.Approximately two months post-operatively, the patient developed a wound-healing disorder and protrusion.On (b)(6) 2016, the fortiva graft and breast implant were explanted.The left breast was irrigated with saline and antimicrobial therapy was initiated.During the explantation procedure, it was noted that 1/3 of the graft had disintegrated and the matrix margins were irregularly shaped.A visible film was also noted to be present on the graft and the sutures on the pectoralis major were weak.

• Brand Name: FORTIVA PORCINE DERMIS
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): RTI SURGICAL, INC.; 11621 research circle; alachua FL 32615
• Manufacturer Contact: karen britt ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 5825861
• MDR Text Key: 50540291
• Report Number: 3002924436-2016-00008
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/24/2017
• Device Lot Number: MP150701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2015
• 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
• Treatment: BREAST IMPLANT
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR