MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH FORTIVA PORCINE DERMIS

Lot Number MP150701

Device Problems Degraded (1153); Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Capsular Contracture (1761)

Event Date 10/06/2016

Event Type  Injury  

Manufacturer Narrative

Method: (b)(4) conducted a re-review of the product history record for fortiva porcine dermis, packaging production records, environmental monitoring, product specification, distribution database, and the complaint database for related complaint associated with the lot.Results: there were no departures noted during records re-review.The xenograft underwent a validated sterilization methodology.Tutoplast , which includes terminal sterilization by gamma irradiation after packaging.(b)(4) has manufactured and distributed (b)(4) fortiva procine dermis from lot mp150701 without related complaints.Environmental monitoring data generated during and around the time of processing was acceptable.According to records re-review, serial id (b)(4) met all (b)(4) specifications and release criteria prior to distribution.Conclusion: given the facts that: the xenograft underwent a validated sterilization methology, tutoplast, which includes terminal sterilization by gamma irradiation after packaging; serial id (b)(4) met all (b)(4) specifications and release criteria prior to distribution; environmental monitoring data was acceptable; there are no complaints related to the lot associated with infection; and the graft dissolution may be related to a combination of impaired healing and bacterial infection, it is more plausible that the patient's post-operative complications were associated with a source or event extrinsic to the xenograft.Explanted and not available.

Event Description

(b)(4), received a complaint which indicated that a patient underwent a revision surgery for capsular contracture after breast reconstruction with implantation of fortiva (unknown lot number and serial number) on (b)(6) 2016.This revision did not achieve aesthetically pleasant results and the patient was complaining of lumps on her right breast.At an unknown date the fortiva graft was removed and another one was implanted in order to support the thin skin.A small fluid leak was noted on the right breast (unknown onset).A revision surgery was performed on (b)(6) 2016, at which time dissolution of the fortiva graft was noted.A culture of the fluid was positive for finegoldia magna.The patient was treated with antibiotics.There were no complications reported regarding the left breast.

• Brand Name: FORTIVA PORCINE DERMIS
• Type of Device: PORCINE DERMIS
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industrierstr. 6; neunkirchen am brand, germany 91077 ; GM 91077
• Manufacturer (Section G): RTI SURGICAL, INC; 11621 research circle; alachua FL 32615
• Manufacturer Contact: leila kelly ; 11621 research circle; alachua, FL 32615 ; 3184188888
• MDR Report Key: 6341196
• MDR Text Key: 67801338
• Report Number: 3002924436-2017-00003
• 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
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• 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: 01/27/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR