MAUDE Adverse Event Report: SYNTHES (USA); DURA SUBSTITUTE

Device Problems Difficult to Remove (1528); Material Separation (1562); Separation Failure (2547)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information was not provided by reporter but has been requested.Additional event information has been requested and is pending response from reporter.This report is for an unknown dura graft product.Product number and lot number were not provided by reporter.Additional information is pending response from reporter.Implant and explant dates are unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the dura graft split and the inner layer was tightly adherent to the brain in a patient who had undergone a dural graft procedure.In this case, surgeon needed to access the temporal lobe and the surface of the brain was injured in removing the graft.This area was resected so there were no adverse consequences to the patient.The graft seems to work for the two weeks after implantation but the graft mostly overlies silastic [material] and only a small area of brain.Surgeon will wait for three months before performing another resection procedure.This report is for an unknown dura graft product.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Update received at 10/30/15 - for this event, surgeon was not able to remove the synthecel from the arachnoid because it was adhered (product delaminated).He left the thin layer of adherent synthecel material in place and closed the patient.(it was unclear if he left all of the synthecel material).The only graft in the patient was synthecel.Surgeon tried to remove the synthecel graft from the patient but stopped because he was concerned that he would damage underlying tissues.The bottom layer is synthecel that adhered to the arachnoid.This layer was not removed from the patient.The arachnoid was intact, therefore the synthecel was not in direct contact with the brain tissue or blood vessel walls.There was no harm to the patient.He observed no inflammatory on the brain where synthecel was adhered.The surgeon was able to remove the top layer of synthecel easily from the adhered layer of synthecel along a plane of the material under a microscope and micro-dissection tools.He was not able to easily dissect the adhered layer of synthecel away from the arachnoid.Synthecel adhered to the arachnoid more than would the dura.Additional information to include: definitive treatment of the patient.Will either excise material or implant neurostimulators.Additional information received from meeting minutes on (b)(6) 2015.The surgeon used synthecel on an epilepsy patients where he knows he will re-operate on the patient.1st procedure - he will remove the bone flap and the dura.He places a neuro monitor directly in contact with the arachnoid.The neuro monitor is made out of platinum and silastic.Covers the neuro monitor with synthecel.Places titanium strips over the synthecel and closes the skin over the titanium strips.He monitors the patient from between 10 days to 3 weeks.He may apply a voltage through the monitor to stimulate the brain during this time.2nd procedure (10days to 3 weeks after the 1st procedure): he will remove the titanium strips, synthecel and monitor.Places a new sheet of synthecel in direct contact with the arachnoid.Sutures the synthecel in place.Places titanium strips over the synthecel and closes the skin over the titanium.3rd procedure (6 weeks to 4 months after the 2nd procedure).

Manufacturer Narrative

(b)(4).The root cause of this issue is unknown, product was not returned and no lot number was provided.Following a discussion between the complainant and product development, an additional review is not required, the complaint condition was confirmed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: DURA SUBSTITUTE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5150459
• MDR Text Key: 28297436
• Report Number: 2520274-2015-16653
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention