MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2018-08-27 for DURASEAL XACT, UNKNOWN XXX-DURASEAL XACT manufactured by Integra Lifesciences Corp.
[118306908]
It is unknown if the device involved will be returned to the manufacturer for evaluation. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation. Doi: https://doi. Org/10. 1155/2018/4189518.
Patient Sequence No: 1, Text Type: N, H10
[118306909]
Case reports in anesthesiology (2018) published "percutaneous epidural hydrogel sealant for the treatment of spontaneous intracranial hypotension: a case report of chronic thoracic neuralgia and technical lessons learned". The objective of the case report was to highlight technical lessons learned and report a postprocedural adverse event of chronic thoracic neuralgia. The authors intend to expound on the critical lessons learned regarding needle size, needle tip placement, rate of injection of sealant, and meaningful endpoints to injectate volume that will be useful to clinicians considering this treatment modality. Its the hope that the report would ultimately contribute to the safe and effective delivery of this valuable surgical sparing technique for other patients. Case description: a (b)(6)-year-old female with a radiographically confirmed anterior dural tear at t10? T12 on mri causing refractory spontaneous intracranial hypotension headaches. She had failed multiple epidural blood patch placements (6 total) over a three-month period. Her headaches were severely disabling, adversely affecting her quality of life and prevented her from working. The headaches required her to remain mostly recumbent for symptom palliation. A ct-guided percutaneous epidural placement of a synthetic absorbable sealant (duraseal) using a right transforaminal approach at t10-t11 and t11-t12 was planned. The hydrogel sealant was prepared according to package insert instructions; however, step 7 was omitted as the spray tip was not needed for percutaneous injection of the hydrogel sealant. Instead, the applicator was directly attached to the tuohy needle hub using the luer lock mechanism. After placement of a 20-gauge tuohy needle at the t11-t12 level, 2. 5ml of sealant was slowly injected. The goal volume of 4ml was not achieved secondary to plugging of the material within the needle. Next an 18-gauge tuohy needle was used for transforaminal placement of the sealant at t10-t11 with the goal volume of 5 ml. The final needle tip location was placed slightly more ventral compared to the initial injection at t11-12 as the dural defect had previously been identified to be more ventral in location. In addition to the larger gauge tuohy needle, a faster injection rate was used at this level in order to avoid premature plugging of the hydrogel material within the needle. The patient experienced severe localized back pain towards the end of the target injectate volume. Immediate postprocedure ct images were obtained. At the t11-t12 level, a substantial portion of the hydrogel complex was located along the exiting spinal nerve root. At t10-t11, the majority of the volume resided extradural within the spinal canal resulting in significant leftward displacement of the spinal cord. The patient remained without signs of neurologic compromise throughout an extended observation period. She was discharged home with postprocedure instructions and oxycodone for pain control. The patient presented to the emergency department with unremitting back pain later the same day and was admitted for pain control and observation. A mri of the spine showed hydrogel sealant material impression on the right dorsolateral surface of the spinal cord at the t10-t11 level with normal cord signal. The patient subsequently developed signs and symptoms consistent with a concordant right-sided dermatomal thoracic neuralgia, presumably due to mass effect on the lower thoracic spinal nerve roots, but did not demonstrate any myelopathy. She was started on gabapentin and amitriptyline and continued on oxycodone for breakthrough pain. The patient? S postural headache completely resolved within hours of the procedure. She was discharged home after a three-day hospital stay. She was able to return to work after four months. Five months after the procedure the patient remained headache free, but she continued to suffer from chronic mild thoracic neuralgia. Her neuropathic symptoms steadily improved and were well controlled with topiramate, amitriptyline, and as needed tramadol.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2018-00038 |
| MDR Report Key | 7818667 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-01 |
| Date Mfgr Received | 2018-08-31 |
| Date Added to Maude | 2018-08-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORP |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURASEAL XACT, UNKNOWN |
| Generic Name | DURASEAL SPINE |
| Product Code | NQR |
| Date Received | 2018-08-27 |
| Catalog Number | XXX-DURASEAL XACT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORP |
| Manufacturer Address | 311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 18 | 2018-08-27 |