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

Lot Number NZ16300081

Device Problem Degraded (1153)

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880)

Event Date 09/06/2018

Event Type  Injury  

Manufacturer Narrative

A comprehensive re-review of records is being conducted with results not available at the time of this report.This review includes manufacturing records, sterilization reports, quality control / assurance review and release, and review of complaints database for related complaints for the lot.Once results are available, a follow up report will be submitted.

Event Description

Rti surgical, inc (rti) received a complaint on (b)(6) 2018 indicating that a patient was implanted with an integra bovine pericardium dural graft and developed a pseudomeningocele, requiring the graft to be replaced.The patient is a female with chiari malformation who underwent decompression in (b)(6) 2018.She developed headaches and posterior neck swelling in late (b)(6) 2018 from a pseudomeningocele.The patient was monitored for 2 weeks with a repeated mri showing an enlarging pseudomeningocele as well as worsening of symptoms.She was taken back to surgery on (b)(6) 2018 to repair the cerebrospinal fluid leak.Complete breakdown of the dural graft was noted during surgery.The graft was replaced utilizing a graft from a different manufacturer.Additional information has been requested.To date, rti has not received any additional information.

Manufacturer Narrative

A comprehensive re-review of manufacturing records was conducted.Bovine pericardium implants undergo a validated sterilization method; tutoplast® which includes terminal sterilization by gamma irradiation after packaging.There were two departures noted during records re-review.One departure indicated that the bioburden exceeded the action limit.The other departure indicated that the bioburden for the sodium chloride solution exceeded the action limit.Both departures did not affect the complaint graft since it was not part of the tutoplast batches affected by them.Manufacturing records indicate that serial id (b)(4) manufactured from lot nz16300081 met all specification requirements at the time of release.To date, rti/tmi has manufactured and distributed (b)(4) bovine pericardium implants from lot nz16300081 without related complaints for the lot.Based on our records re-review and "the" complaint information provided to date, it is more plausible that the patient's post-operative complications are associated with an event or source extrinsic to the xenograft implant.

• Brand Name: INTEGRA BOVINE PERICARDIUM DURAL GRAFT
• Type of Device: BOVINE PERICARDIUM DURAL SUBSTITUTE GRAFT
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; indrustriestr 6; neunkirchen am brand, 91077 ; GM 91077
• MDR Report Key: 7986364
• MDR Text Key: 124490923
• Report Number: 3002719998-2018-00012
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• PMA/PMN Number: K132850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/31/2022
• Device Lot Number: NZ16300081
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other