MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH DURAFELX; BOVINE PERICARDIUM DURAL GRAFT

Lot Number NZ18450004

Device Problem Degraded (1153)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

The xenograft was not available for return.Therefore, a comprehensive records re-review of manufacturing records, sterilization run reports, quality control/assurance reviews and release, and complaint database for related complaints associated with the lot was conducted.There were no departures noted during records re-review for lot nz18450004.All bovine pericardium implants undergo a validated sterilization method (tutoplast® which includes terminal sterilization by gamma irradiation after packaging.Manufacturing records indicate that all xenografts implants manufactured from this lot met all specifications and release criteria prior to distribution.To date, rti has manufactured and distributed a total of 10 xenograft implants from the lot without related complaints.Additional information is needed to better understand and possibly explain the complications reported, including information regarding the suture procedure and suture material utilized, whether the membrane was fixed under tension, membrane rehydration procedure prior to use, and whether the patient has an allergy to bovine collagen and/or bovine material.

Event Description

Rti surgical, inc (rti) received an adverse event from integra lifesciences on 10/02/19.The reported complaint indicated that a patient underwent implantation of a duraflex (bovine pericardium membrane) graft on (b)(6) 2019.On (b)(6) 2019, the patient was taken back to the operating room due to a hemorrhage.At that time, the surgeon noted that the duraflex graft had disintegrated.The sutures were still present, but a film was left behind with no sign of the graft.Attempts have been made to obtain additional patient clinical information.To date, rti has not received any additional information.

• Brand Name: DURAFELX
• Type of Device: BOVINE PERICARDIUM DURAL GRAFT
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestr 6; neunkirchen am brand, 91077 ; GM 91077
• Manufacturer Contact: leila kelly ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 9272884
• MDR Text Key: 166195602
• Report Number: 3002719998-2019-00021
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: NZ18450004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other