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

Model Number 42546

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Fatigue (1849); Headache (1880); Hemorrhage, Cerebral (1889); Neck Pain (2433)

Event Date 03/20/2019

Event Type  Death  

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

Tsung-hsi yang, jung-tung liu, fook-how chan.Multiple massive intratumoral hemorrhages of metastatic brain melanoma after ventriculoperitoneal shunt.Formosan journal of surgery 52 (2019).Doi: 10.4103/fjs.Fjs_107_18 abstract: a (b)(6) year-old male presented with sudden-onset headache, diplopia, and unsteadiness due to a posterior fossa hemorrhagic melanoma causing hydrocephalus.Computed tomography of the brain showed a 2.3 cm × 2.0 cm hemorrhagic tumor in the cerebellar vermis and a concomitant fourth ventricular hemorrhage.He underwent removal of the tumor and then ventriculoperitoneal shunt insertion for hydrocephalus.Because of his widespread disease, the patient died 2 weeks later from multiple massive intratumoral hemorrhages.To avoid this unfortunate consequence, we discuss the mechanism and suggest methods for treatment improvement.The variable we could control carefully was the opening pressure of the shunt and the flow of cerebrospinal fluid drainage.Setting a higher opening pressure and changing the pressure more slowly should be considered.To achieve this goal, the use of a programmable valve and anti-siphon system should strongly be recommended in these high-risk populations with extremely high bleeding tendency.Reported event.A (b)(6) year-old male was admitted because of a sudden-onset headache, rotatory vertigo, vomiting, loss of balance, and poor coordination.A physical examination revealed a glasgow coma scale (gcs) of e4v5m6, but the patient was mentally slow and disoriented.He had marked truncal ataxia and dysdiadochokinesis in both the hands.His muscle strength, deep tendon reflexes, and sensation were preserved.He had no babinski¿s sign.A 2 cm × 2 cm black nevus with irregular margins was found on the left plantar surface.Computed tomography (ct) of the brain demonstrated a2.3 cm × 2.0 cm hemorrhagic tumor mass with a high-density lesion in the midline of the cerebellar vermis and the left parasagittal region of the cerebellum.Brain magnetic resonance imaging showed a short t1 with contrast-enhancing nodules over the left cerebellar peduncle, left cerebellopontine angle, and left frontal and temporal regions.Multiple ill-defined lower density lesions were found in the subcortical region of the bilateral parietal white matter.Laboratory data showed no bleeding tendency (prothrombin time: 9.6 s; activated partial thromboplastin time: 24.8 s; and platelets: 146000/¿l).The patient underwent a cerebellar tumor resection for biopsy and decompression via a suboccipital craniotomy.Histopathologic examination revealed a metastatic brain melanoma.Postoperatively, the patient¿s gcs was 15, with a relatively slow response.A brain ct image obtained 21 days after the operation revealed hydrocephalus.Symptoms of hydrocephalus, including headache, nausea, vomiting, and unsteady gait, were also noted.The standard vpshunting procedures (medtronic ps valve, high pressure; opening pressure: 14.5 cmh2o) were performed to control the hydrocephalus.After the surgery, the patient¿s response and symptoms improved rapidly.Unfortunately, 10 days after the vp shunt implantation, the patient developed progressive drowsiness, severe posterior neck pain, and headache.A physical examination revealed weaker muscle power on the right limbs, with a score of 3/5 on the british medical research council strength scale, and an increase in the deep tendon reflex.A brain ct scan showed multiple melanoma-related intracerebral hemorrhages (ichs) over the left parietal lobe, right occipital lobe, and head of the caudate nucleus.The rapid worsening of subfalcine herniation with massive intratumoral hemorrhages necessitated an emergency surgery for removal of the ich with shunt ligation.Seven days later, the ct showed more ich and severe brain swelling.The patient¿s poor neurological state and absent brainstem reflexes precluded any contemplation of reoperation, and the patient died 3 days later.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that the doctor thought the death was related to the pressure selection and not the product quality.To improve treatment, the doctor would recommend the use of a programmable valve and anti-siphon system in these high-risk populations with extremely high bleeding tendency.

• 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: 8794634
• MDR Text Key: 151178835
• Report Number: 2021898-2019-00280
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K831678
• 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,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42546
• Device Catalogue Number: 42546
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 08/16/2019
• Supplement Dates FDA Received: 08/26/2019
• 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 Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 50 YR