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

Model Number UNKNOWN-V

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Migration (4003)

Patient Problems Erythema (1840); Fever (1858); Unspecified Infection (1930)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Andrew reisner, alexis d.Smith, david m.Wrubel, bryan e.Buster, michael s.Sawvel, laura s.Blackwell, nealen g.Laxpati, barunashish brahma, and joshua j.Chern.Utility of ventriculogallbladder shunts in complex cases of hydrocephalus related to extreme prematurity.Journal of neurosurgery pediatrics (2021).Doi: 10.3171/2020.9.Peds20522 objective the management of hydrocephalus resulting from intraventricular hemorrhage related to extreme prematurity remains demanding.Given the complexities of controlling hydrocephalus in this population, less commonly used procedures may be required.The authors examined the utility of ventriculogallbladder (vgb) shunts in a series of such children.Methods the authors retrospectively reviewed the medical records of all children who underwent surgery for hydrocephalus in the period from 2011 through 2019 at children¿s healthcare of atlanta.Six patients who underwent vgb shunt placement were identified among a larger cohort of 609 patients who had either a new shunt or a newly changed distal terminus site.The authors present an analysis of this series, including a case of laparoscopy-assisted distal vgb shunt revision.Results the mean age at initial shunt placement was 5.1 months (range 3.0¿9.4 months), with patients undergoing a mean of 11.8 shunt procedures (range 5¿17) prior to the initial vgb shunt placement at a mean age of 5.3 years (range 7.9 months¿12.8 years).All 6 patients with vgb shunt placement had hydrocephalus related to extreme prematurity (gestational age <(><<)> 28 weeks).At the time of vgb shunt placement, all had complex medical and surgical histories, including poor venous access due to congenital or iatrogenic thrombosis or thrombophlebitis and a peritoneum hostile to distal shunt placement related to severe necrotizing enterocolitis.Vgb complications included 1 case of shunt infection, identified at postoperative day 6, and 2 cases of distal shunt failure due to retraction of thedistal end of the vgb shunt.In all, there were 3 conversions back to ventriculoperitoneal or ventriculoatrial shunts due to the 2 previously mentioned complications, plus 1 patient who outgrew their initial vgb shunt.Three of 6 patients remain with a vgb shunt, including 1 who underwent laparoscopy-assisted distal shunt revision 110.5 months after initial vgb shunt insertion.Conclusions placement of vgb shunts should be considered in the armamentarium of procedures that may be used in the particularly difficult cohort of children with hydrocephalus related to extreme prematurity.Vgb shunts show utility as both a definitive treatment and as a ¿bridge¿ procedure until the patient is larger and comorbid abdominal and/or vascular issues have resolved sufficiently to allow conversion back to ventriculoperitoneal or ventriculoatrial shunts, if needed.Reported events.A boy, born at 29 weeks¿ gestation weighing 1.04 kg, received his first shunt at 6.0 months of age and underwent 15 shunt procedures before receiving a vgb shunt.He received his initial vgb shunt at the age of 12.8 years.This shunt lasted 3.3 years, but ultimately the distal end retracted from the vgb shunt and it was converted back to a vp shunt.It was indicated that the patient presented with a distal malfunction secondary to shunt retraction from the gallbladder.The peritoneal space was more capacious than previously, and the shunt was converted to a vp shunt with repair of the gallbladder during open laparotomy.This patient died at the age of 19.6 years from respiratory problems associated with prematurity and unrelated to the vgb shunt.A boy, born at 24 weeks¿ gestation weighing 0.62 kg, received his initial shunt at 3.7 months of age and underwent 10 shunt procedures prior to the initial vgb shunt, which he received at 7.9 months of age¿the youngest patient in this series.He had a history of previous infection with staphylococcal meningitis.Csf cultures and markers confirmed csf sterility prior to vgb shunt placement.However, on postoperative day 6 the patient developed a fever, elevated white cell count, and erythema of the distal incision.This prompted a shunt tap, which confirmed a gram-negative infection (gram-variable rods).It is unknown if the source was from the gallbladder, peritoneum, or contamination of extra-peritoneal soft tissue.All shunt hardware was removed and an external ventricular drain (evd) was placed.Sterile csf was confirmed 7 days later and a ventricular access device was placed until the infection cleared and other prematurity-associated issues resolved.At 2.3 months after vgb removal a va shunt was placed.A girl, born at 25 weeks¿ gestation weighing 0.60 kg, received her first shunt at 3.0 months of age and underwent 17 shunt procedures prior to the initial vgb shunt placement, which she received at the age of 5.8 years.After 16.6 months she had outgrown the vgb shunt and underwent a conversion back to a va, which was inserted into the contralateral subclavian vein.It was indicated the vgb shunt malfunctioned 16.6 months after insertion.Laparoscopic lysis of adhesions created a capacious peritoneal space, and the vgb was converted to a vp shunt.In a period of 9 months the patient underwent 4 vp revisions, and ultimately a va shunt was placed in the contralateral subclavian vein.- a boy, born at 25 weeks¿ gestation weighing 0.95 kg, received his first shunt at the age of 9.4 months and underwent 9 shunt procedures before receiving his initial vgb shunt at 2.0 years of age.After 9.2 years with the vgb shunt, he presented with clinical and head ct features consistent with a shunt malfunction.The shunt series revealed the shunt terminus in the right upper quadrant, but an abdominal ultrasound was suspicious for migration of the shunt tip out of the gallbladder.This was confirmed intraoperatively.The shunt was laparoscopically revised and the distal end was reinserted into the gallbladder.It was indicated that an attending pediatric surgeon with advanced laparoscopic training and experience proceeded with the laparoscopic approach because she had determined that adhesiolysis and gallbladder exposure could be optimized with endoscopic techniques.Access to the abdomen was gained through the umbilicus, and two working trochars were introduced under direct visualization.Following lysis of adhesions, the fundus of the gallbladder and shunt were identified.The shunt tubing had migrated out of the gallbladder with growth of the patient.The fibrin sheath surrounding the shunt was excised in order to gain more intra-abdominal length of the shunt tubing.The shunt was then reintroduced into the gallbladder through the prior cholecystostomy site and secured to the fundus of the gallbladder by using intracorporeal suturing with a v-loc suture to prevent dislodgement and leakage of bile.

• Brand Name: UNKNOWN VALVE/SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 11734026
• MDR Text Key: 263443733
• Report Number: 2021898-2021-00099
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2021

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: UNKNOWN-V
• Device Catalogue Number: UNKNOWN-V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2021
• Initial Date FDA Received: 04/27/2021
• 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): Hospitalization; Required Intervention