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

Model Number UNKNOWN-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hematoma (1884); Hemorrhage, Intraventricular (1892); Loss of consciousness (2418)

Event Date 04/27/2017

Event Type  Death  

Manufacturer Narrative

Please note that this age is the average age of the patients reported in the article.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

Weiyi gong, li xu, peng yang, zhengquan yu, zhong wang, gang chen, shiming zhang and jiang wu.Characteristics of delayed intracerebral hemorrhage after ventriculoperitoneal shunt insertion.Oncotarget 8 (2017).Abstract background: delayed intracerebral hemorrhage after ventriculoperitoneal (vp) shunt insertion is rare and has not been well investigated previously.Its characteristics is still unknown.Objective: we reported 12 patients with delayed intracerebral hemorrhage after vp shunt to investigate the potential risk factors and the outcome.Results: 12 patients (1.59%) of all the 754 hydrocephalus had delayed intracerebral hemorrhage after vp shunt insertion.Four patients were women and 8 patients were men, ranging in age from 50 to 76 years.The delayed cerebral hemorrhage from day 3 to day 7 post operation was diagnosed by repeated ct.The delayed intracerebral hemorrhage was significantly related to age, prior craniotomy operation history and manipulation of valve system (3¿7 days).Neither gender sexuality nor potential risk factors for postoperative hemorrhage (including anticoagulation/antiplatelet status, liver disease, diabetes, hypertension), time of shunt attempt affected the happen of delayed intracerebral hemorrhage.Materials and methods: the clinical characteristics including sex, age, anticoagulation/antiplatelet status, liver disease, diabetes, hypertension, craniotomy operation history, manipulation of valve system and time of shunt attempt of 754 patients who were surgically treated of vp shunt at the first affiliated hospital of soochow university between 2007 and 2013 were reviewed retrospectively.The potential risk factors of the delayed intracerebral hemorrhage were statistically analyzed.Conclusions: this study summarizes the presentation and outcome of a series of 12 patients with delayed intracerebral hemorrhage after vp shunt.Age = 60 years, prior craniotomy operation and manipulation of the valve system are statistically significant to the delayed hematoma secondary to vp shunt.Reported event.A (b)(6) year old male underwent a decompressive left frontotemporal craniectomy for hypertensive intracerebral hemorrhage 3 months previously.Ct showed hydrocephalus with interstitial edema capping the frontal horns of the lateral ventricles.Preoperative neurological examination was unremarkable.A vp shunt was placed with a medtronic strata programmable valve system (pressure level, 1.5).A ventricular catheter was inserted into the anterior horn of the right lateral ventricle at the first attempt.Twenty four hours after surgery, ct imaging was normal and the pressure of the left decompressive window decreased.On postoperative day 3, the pressure of decompressive window increased and the patient became unconscious.Emergent ct showed a large hematoma along the path of the catheter associated with an appreciable intraventricular hemorrhage.Unfortunately, the patient died suddenly before the evacuation of the hematoma.

• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7433100
• MDR Text Key: 105561614
• Report Number: 2021898-2018-00196
• 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: 04/16/2018

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?: No
• 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
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 04/16/2018
• 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): Death
• Patient Age: 62 YR