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

Lot Number NZ15120219

Device Problem Material Rupture (1546)

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880); Vomiting (2144)

Event Date 02/26/2018

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 run reports, environmental monitoring review, quality control/assurance review and release, and review of the 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 indicating that a patient had a laminectomy for recurrent tethered cord on (b)(6) 2018 where no graft was implanted.On (b)(6) 2018, the patient underwent a revision surgery due to a cerebrospinal fluid (csf) with implantation of an integra bovine pericardium dural graft (lot nz15120128; serial (b)(4)).The suture line was covered with tisseel (baxter), duragen® ((b)(4)) was implanted over the graft and more tisseel was applied over the duragen®.The patient developed postural headaches and vomiting.Graft failure was suspected, and upon surgical intervention on (b)(6) 2018, it was found that the graft had a hole directly in the center of it with leakage along the suture lines.Another integra bovine pericardium dural graft was implanted (lot nz15120219; serial (b)(4)).Once again, the suture line was covered with tisseel (baxter), duragen® ((b)(4) ) was implanted over the graft and more tisseel was applied over the duragen®.Days later, the patient became symptomatic (unknown specific symptoms).On (b)(6) 2018 another surgery was performed and the graft was noted to have two transversely oriented linear tears in the central portion, one of which was leaking csf freely while the other appeared to be partial thickness.This time, the graft was replaced with a duraguard® graft (different manufacturer).Duragen® was implanted over the graft.As of (b)(6) 2018, when (b)(4) (distributor of the graft) had a call with the surgeon, the patient was still in the hospital with a drain.The patient had eosinophilia present in the csf.No marked eosinophilia was noted in the peripheral blood.

Manufacturer Narrative

The xenograft was not returned for evaluation.Therefore, a comprehensive records re-review was conducted, which included manufacturing records, sterilization run reports, quality control/assurance reviews and release, and the complaints database for related complaints associated with the lot.There were two departures associated with the k batch.One departure stated that the humidity was exceeded for a brief period (78% instead of 75% for one hour).Investigation concluded that there was no risk to the product.The second departure stated that there was a power failure outside normal working hours.Microbiological testing in the clean rooms as well as additional testing of the hpw for endotoxins and bioburden showed no abnormalities.All devices in the bovine area worked normally.There was no risk for the product due to this departure.It can be concluded that none of the above-mentioned departures had a negative impact on the quality of the complaint products.Environmental data generated during and around the time of processing of this graft were acceptable.Manufacturing records indicate that serial id (b)(4) manufactured from lot nz15120219 met all specification requirements at the time of release.To date, rti/tmi has manufactured and distributed 41 bovine pericardium implants from lot nz15120219, without related complaints for either 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 GBMH; industriestr 6; neunkirchen am brand, germany
• MDR Report Key: 7374166
• MDR Text Key: 103612056
• Report Number: 3002719998-2018-00004
• 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: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/31/2020
• Device Lot Number: NZ15120219
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR