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

Model Number PD2025

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

Patient Problems Seroma (2069); Hernia (2240)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

The information provided to date indicated that the xenograft remains implanted and not available for evaluation.Therefore, a comprehensive re-review will be conducted of the manufacturing records, sterilization run reports, environmental monitoring results, quality control / assurance reviews and release, and the complaint database for related complaints.Once results are available, a follow up will be submitted.

Event Description

Rti surgical, inc (rti) received a complaint notification on (b)(4) 2017 indicating that a patient underwent implantation of a fortiva porcine dermis at an unknown date, as part of a hernia repair clinical study.On (b)(6) 2017, the patient developed a seroma (unknown location).To date, rti has not received any additional information.

Manufacturer Narrative

Methods: the xenograft was not returned for evaluation.Therefore, a comprehensive re-review of manufacturing records, sterilization run reports, quality control / assurance reviews and release, and the complaint database for related complaints associated with the lot was conducted.Results: there were two departures noted during records re-review for lot mp152601.One departure was associated with exceeded airborne bioburden.However, additional testing was performed and was acceptable.Bioburden testing on all the grafts was within specification.The second departure was associated with the storage temperature being exceeded in the abattoir.A risk analysis indicated that there was no risk to the product quality due to these departures.Xenografts manufactured from lot mp152601, underwent a validated sterilization methodology: tutoplast®, which includes terminal sterilization by gamma irradiation after packaging.Serial id (b)(4) met all rti/tmi specifications and release criteria prior to distribution.To date, rti/tmi has manufactured and distributed a total of 117 xenograft from the lot without related complaints.Based on our records re-review and the complaint information provided to date, it is more plausible that the patient's operative complications were associated with an event of source extrinsic to the xenograft implants.

• Brand Name: FORTIVA PORCINE DERMIS
• Type of Device: PORCINE DERMIS - SURGICAL MESH
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestrasse 6; neunkirchen am brand, germany 91077 ; GM 91077
• Manufacturer Contact: leila kelly ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 6999293
• MDR Text Key: 90967797
• Report Number: 3002719998-2017-00034
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 04041543312065
• UDI-Public: (01)04041543312065(17)180731(10)MP152601
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2018
• Device Model Number: PD2025
• Device Catalogue Number: PD2025
• Device Lot Number: MP152601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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