MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN VALVE/SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number UNKNOWN-V

Device Problem Insufficient Information (3190)

Patient Problems Dysphagia/ Odynophagia (1815); Muscle Weakness (1967); Vertigo (2134); Brain Injury (2219); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Numbness (2415); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: unknown-s, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Hassan a.Khayat, tariq al-saadi, valerie panet-raymond, roberto jose diaz.Surgical management of isolated fourth ventricular hydrocephalus associated with injury to the guillain-mollaret triangle.World neurosurgery 122 (2019).Doi: org/10.1016/j.Wneu.2018.10.091.Background: the occurrence of isolated fourth ventricle and injury to the guillain-mollaret triangle in the setting of posterior fossa ependymoma represents a new association.In this case report, we discuss the clinical, theoretical, and therapeutic aspects of this problem.We describe a lateral transcerebellar trajectory and shunt valve configuration for safe fourth ventricle shunting in a patient with prior posterior fossa surgery.Case description: a (b)(6) woman underwent subtotal resection of a fourth ventricle ependymoma (world health organization grade iii) followed by radiation therapy to control the residual tumor.Her course was complicated by a cerebral abscess and subsequent communicating hydrocephalus, for which she received a lateral ventriculoperitoneal shunt.After placement of the lateral ventricle shunt, there was a progressive increase in the volume of the fourth ventricle over the next 2 years, from 2.5 to 12.0 ml.She developed palatal myoclonus, hand incoordination, bilateral foot numbness, and progressive ataxia.Neuroimaging also revealed hypertrophic degeneration of the inferior olivary nuclei bilaterally.The isolated fourth ventricle was treated by a separate fourth ventriculoperitoneal shunt inserted through a lateral transcerebellar trajectory.A programmable variable pressure valve was implemented.Conclusions: development of an isolated fourth ventricle and injury to the guillain-mollaret triangle in the setting of fourth ventricular ependymoma is a newly encountered complication.Choice of treatment modality and timing of intervention should be carefully considered on a case-by-case basis.The data presented in this report may assist in the selection of surgical treatment for isolated fourth ventricle.Reported events.A (b)(6) otherwise healthy woman presented to an outside center in march 2016 with progressive headache, nausea, and vomiting over a period of 3 months.Her examination was positive for diplopia, nystagmus, vertigo, and ataxia.Initial magnetic resonance imaging (mri) showed a posterior fossa mass occupying most of the fourth ventricle measuring 2.7x1.9x2.3 cm.No hydrocephalus was noted at this time.A midline suboccipital craniotomy was performed for tumor resection with residual tumor remaining at the obex.Pathology demonstrated an anaplastic ependymoma (world health organization grade iii).Postoperatively, the patient developed an acute infection at the surgical site with a subcutaneous collection.Although the inflammatory process was progressive with a formation of granulation tissue, no pathogen grew on cultures, and the local biopsy revealed only reactive inflammatory cells with no evidence of tumor seeding.This local infection progressed further, making its way through the surgical incision into the intradural compartment via a left parietal frazer burr hole, forming a cerebral abscess in the left parietal area.The abscess was drained, and the patient was started on antibiotics.Three weeks later, she developed acute deterioration in level of consciousness secondary to acute hydrocephalus, which was treated with emergent shunting through a right parietal approach and using a medium pressure valve.She further developed a left subdural collection that required insertion of a subdural-to-peritoneal shunt with an adjustable valve (strata ii; medtronic, minneapolis, minnesota, usa) set on 0.5.Once stable, she received radiation therapy 59.4 gy in 33 fractions directed to the tumor bed at the fourth ventricle.The patient had satisfactory results after radiation therapy with good control of residual tumor.She was referred to the montreal neurological institute for assessment of persistent severe vertigo, which was noted after placement of her subdural-to-peritoneal shunt.She was also assessed by the otolaryngology and neurology services with no significant improvement.Physical examination in january 2017 was remarkable for diplopia, pendular nystagmus, ataxia, and bilateral dysmetria with unsteady gait that had been gradually worsening since the insertion of her lateral shunt early in april 2016.Furthermore, she developed mild dysphagia on swallowing and was noted to have pharyngeal myoclonus.Mri scans obtained in january and march 2017 revealed interval hypertrophic degeneration of bilateral inferior olivary nuclei suggestive of injury to the guillain- mollaret triangle.In addition, serial measurements showed a progressive increase in the fourth ventricle volume after the insertion of the lateral ventriculoperitoneal shunt in april 2016.The lateral and third ventricles were of normal size throughout this period.No intervention was performed for 1 year, as the patient remained clinically stable.However, in the period from february 2018 to june 2018, the patient began to develop worsening ataxia.Mri obtained in april 2018 showed persistent enlargement of the fourth ventricle.In july 2018, the patient¿s condition deteriorated such that she had more difficulty with gait and maintaining an upright posture.Although these sequelae were present after her initial surgery, there was marked decline in her functional status.She also developed incoordination and weakness of the hands and numbness to both feet.Computed tomography (ct) scan obtained at this point showed marked isolated enlargement of the fourth ventricle reaching 12 ml in volume.After having a detailed discussion with the patient, the decision was made to insert a separate fourth ventriculoperitoneal shunt to drain the fourth ventricle.The entry point for the ventricular catheter was chosen to be 1 cm below the transverse sinus and 2 cm posterior to the sigmoid sinus.A lazy-s skin incision was centered over the previously determined entry point and placed in a paramedian location to avoid overlapping with her previous midline incision and her previous right parietal shunt incision.Under this new incision, a burr hole was made.The peritoneum was then opened over the ipsilateral right upper quadrant, and the peritoneal catheter was tunneled.The ventricular catheter was then inserted in a trajectory parallel to the floor of the fourth ventricle.Using a navigated stylet (pci handle kit; medtronic) and guidance-mode navigation (stealth; medtronic), the tip of the catheter was directed exactly to a target point set at the center of the fourth ventricle in the sagittal and coronal plane.A programmable burr hole valve (strata ii), set at 1.5, was attached to the ventricular catheter.The patient tolerated the procedure very well and showed improvement in her symptoms over the next 2 weeks.She is beginning to regain her ability to mobilize and has resolution of hand weakness and incoordination as well as foot numbness.She is tolerating oral feeding with normal swallowing function.Postoperative volumetric ct scan obtained at 2 weeks showed a reduction in the fourth ventricular volume to 11.2 ml.The strata ii valve was adjusted to setting 1.0 at 2 weeks after surgery.Follow-up at 6 weeks after surgery demonstrated a reduction in fourth ventricular volume to 8.9 ml.

• Brand Name: UNKNOWN VALVE/SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8188416
• MDR Text Key: 131396294
• Report Number: 2021898-2018-00581
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-V
• Device Catalogue Number: UNKNOWN-V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR