MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH DURAFLEX SUTURABLE GRAFT; BOVINE PERICARDIUM DURAL SUBSTITUTE GRAFT

Model Number	BP10405
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Purulent Discharge (1812)
Date of Event	01/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The graft was explanted and not available for evaluation.Therefore, our investigation is based on a comprehensive review of manufacturing records and evaluation of patient medical information requested.Once the results of the investigation are available, a follow up report will be submitted.
Event or Problem Description
It was reported that a patient with chiari malformation underwent a surgical procedure on (b)(6) 2020 with implantation of an rti surgical, inc.Duraflex suturable graft.The first week of (b)(6) 2021, the patient developed a cerebrospinal fluid (csf) leak.On (b)(6) 2021, the graft was resutured and augmented with muscle.Two days post-operatively, a csf leak developed and a lumbar drained was placed for 5 days.Another csf leak developed and vp shunt was placed on (b)(6) 2021.On (b)(6) 2021, the patient had purulent csf drainage.On (b)(6) 2021, the physician performed a re-exploration of the suboccipital wound with removal of the graft, vp shunt and implant of new graft (unknown) and placement of an external ventricular csf drain.The explanted duraflex graft was described as having a 1.5cm hole in the center, the graft was adherent to parenchyma.To date, requested additional information has not been provided.
Additional Manufacturer Narrative
The graft was explanted and not available for evaluation.However a photograph was provided that noted the surgical site, sutures visible.The graft was not easily visualized in the picture.Bovine pericardium implants undergo a validated sterilization method; tutoplast® which includes terminal sterilization by gamma irradiation after packaging.No departures were noted during records review that would negatively impact the manufacturing and processing of bovine pericardium grafts from lot nzs18500098.Serial id (b)(6) manufactured from the lot met all specification requirements at the time of release.There are not related complaints for the lot.Integra duraflex suturable dural grafts are a natural, resorbable collagenous device.The absorption and tissue regeneration processes begin one to two days after implantation and may last for weeks on months.The most common causes for failure of the regeneration process are associated with the medical history of the patient (i.E.Diabetes, allergic reaction) and level of compliance with post-operative instructions.Additional information is needed to better understand and possibly explain the complications reported, including whether the patient has an allergy to bovine collagen and/or bovine material, patient's medical history and compliance with post-operative care.It is unknown whether the graft was punctured during surgery or sutured with tension, or in vivo by an inadequate regeneration process.

• Brand Name: DURAFLEX SUTURABLE GRAFT
• Common Device Name: BOVINE PERICARDIUM DURAL SUBSTITUTE GRAFT
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; industriestr 6; neunkirchen am brand, 91077 ; GM 91077
• MDR Report Key: 11516068
• Report Number: 3002719998-2021-00009
• Device Sequence Number: 3804381
• Product Code: GXQ
• UDI-Device Identifier: 10381780511342
• UDI-Public: (01)10381780511342(17)250430(10)NZS18500098
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K132850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: BP10405
• Device Catalogue Number: BP10405
• Device Lot Number: NZS18500098
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention