MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH TUTOMESH BOVINE PERICARDIUM

Lot Number NZ14070195

Device Problem Insufficient Information (3190)

Patient Problem Seroma (2069)

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

Method: rti/tmi will be conducting a re-review of product history record for tutomesh bovine pericardium, packaging production records, environmental monitoring, product specification, distribution database, and the complaint database for related complaints associated with the lot.Results of the investigation are pending and will be reported as soon as available.Device not available.

Event Description

Rti surgical, inc.(rti) and tutogen medical (b)(4), a wholly owned subsidiary of rti, received a complaint originally on 11/07/2016 (reported on medwatch #3002924436-2016-00016).The reported complaint indicated that after a bilateral nipple-sparing mastectomy, the patient returned for follow up with seroma development and rotation of the graft on the left side.On 12/02/2016, it was reported that there was an additional graft implanted on the right breast and that both were explanted on this date.To date, rti has not received additional information.

Manufacturer Narrative

Method: rti/tmi conducted a re-review of the product history record for tutomesh bovine pericardium, packaging production records, environmental monitoring, product specification, distribution database ad the complaint database for related complaints associated with the lot.Results: there were two departures noted during records re-review.One departure was associated with the temperature in the cold storage not logged.To exclude a device failure, two data loggers were placed in the cold storage, with both showing the same data.It was concluded that it was not an equipment failure, but a failure to start the data logger.There were no temperature alarms during the departure time (from a separate alarm system).The second departure was associated with product barcodes that could not be read due to a printing mistake.The printing setup was changed and the barcodes were re-printed.Investigation indicated that there was no impact to product safety due to these departures.The xenograft underwent a validated sterilization methodology, tutoplast®, which includes terminal sterilization by gamma irradiation after packaging.Rti/tmi has manufactured and distributed 4 tutomesh bovine pericardium xenografts from lot nz14070195 without related complaints.Environmental monitoring data generated during and around the time of processing were acceptable.According to records re-review, serial (b)(4) met rti/tmi specifications and release criteria prior to distribution.Conclusion: given the facts that: the xenograft underwent a validated sterilization methodology, tutoplast® which includes terminal sterilization by gama irradiation after packaging; serial (b)(4) met all rti/tmi specifications and release criteria prior to distribution; environmental monitoring data was acceptable; there are no related complaints associated with the lot; and seroma is a common complication after mastectomy, due to serum accumulation in a dead space in the tissue (after extensive removal of tissue), it is more plausible that the patient's post-operative outcome was associated with a source of event extrinsic to the xenograft.

• Brand Name: TUTOMESH BOVINE PERICARDIUM
• Type of Device: BOVINE PERICARDIUM
• 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 ; 3864188888
• MDR Report Key: 6215847
• MDR Text Key: 63651358
• Report Number: 3002924436-2016-00017
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K081538
• 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,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Lot Number: NZ14070195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other