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

Model Number UNKNOWN-S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Therapeutic Effects, Unexpected (2099)

Event Date 11/30/2019

Event Type  malfunction  

Manufacturer Narrative

Please note that this date is based off the date of publication of the article as the actual event date was not provided.If information is provided in the future, a supplemental report will be issued.

Event Description

Yong han & min chen & jin xu & yongqiang wang & hangzhou wang.Acquired chiari type i malformation managed by expanding posterior fossa volume and literature review.Child's nervous system (2019).Doi: 10.1007/s00381-019-04437-0 abstract purpose the acquired chiari type i malformation is a rare late complication of supratentorial shunting in children which is often accompanied by abnormal cranial vault thickening.Several surgical treatments for this disease have been proposed including supratentorial skull enlarging procedures and subtentorial craniotomy.But there is still debate about the best treatment strategy for this disease.Method and results we reviewed the current knowledge of this disease in the paper.We illustrated one patient of symptomatic acquired chiari type i malformation who had cysto-peritoneal (c-p) shunting and ventriculoperitoneal (v-p) shunting.We observed the csf flow dynamic of this patient at different periods.The acquired chiari type i malformation disappeared on imaging after thinning the occipital planum combined with the standard surgical therapy of chiari decompression.The symptoms of the patient were relieved after surgery.Conclusion overshunting manifestations require prompt recognition and management.Preventive measures should be taken which include making a stringent selection of cases being considered for surgery, avoiding c-p drainage, and placing of a programmable valve as initial treatment of intracranial arachnoid cysts (ac) if shunting is considered.Reported event.- the patient was a 10-year-old girl with a left temporal arachnoid cyst (ac) when she was born.The patient was implanted with a c-p in 2009 and v-p shunt in 2018.Two months after the v-p shunt procedure, the patient came to our hospital because of short paroxysmal non-postural headaches.We ensured that the v-p shunting was working properly.The ct scan showed that the ventricles became smaller than before.Then, the valve pressure of v-p shunting was gradually upgraded to 200 mm h2o.The symptom of the patient was temporarily relieved.With the increase of valve pressure, the severity of the cerebellar tonsil hernia was improved on imaging and arachnoid cisterns around the brainstem became enlarged.With the increase of valve pressure, excessive drainage of csf may be partially improved and csf flow dynamic could probably be changed.It will create the increase of csf in the subarachnoid space.Then, the increased csf will alleviate the downward pressure as the brain tissue pulsates.At the same time, sagging of the brain will be alleviated with the increase of buoyancy created by intracranial csf.But, the patient¿s headache returned one month later.We believe that this is because the limited volume of the cranial cavity is unable to meet the increased csf and the ascending cerebellar tonsillar.Fundus examination revealed papillary edema which means intracranial hypertension.And, eye examination showed decreased vision.These clinical manifestations mean that an urgent surgery is needed.Imaging results also showed thick calvarial bones, small volume subarachnoid spaces, effacement of the arachnoid cisterns, and a crowded posterior fossa with cerebellar tonsillar herniation, all of which could be observed in a patient with accd.So, we decided to augment the intracranial volume.There are two surgical options available, i.E., supratentorial craniotomy and subtentorial craniotomy.As the decrease in the volume of subarachnoid space was most pronounced around the brainstem, we thought that we could improve local csf flow around the brainstem by enlarging the posterior fossa volume.Then, the downward pressure will be partly alleviated as the brain tissue pulsates.But standard surgical therapy for chiari decompression will probably increase the risk of further sagging of the cerebellum.In our surgery, we further reduced the size of the occipital flap to avoid this complication.We modeled the thickened occipital planum to a normal size and subsequently placed back the thinned bone.During the same procedure, a standardized c0 augmentation and c1 laminectomy were given; the circumoccipital fascia was also cut off.The patient¿s headaches diminished 3 days after the operation.Mri which was performed 9 months after the surgery showed an adequate decompression with an obvious increase in the volume of subarachnoid spaces around the brainstem and regression of the caudal tonsillar herniation.The lateral ventricles become enlarged.However, the cyst appeared again.

• Brand Name: UNKNOWN STRATA 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9616097
• MDR Text Key: 198535983
• Report Number: 2021898-2020-00030
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 10 YR