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

Model Number UNKNOWN-S

Device Problems Complete Blockage (1094); Disconnection (1171); Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)

Patient Problems Cyst(s) (1800); Intracranial Hemorrhage (1891); Unspecified Infection (1930); Post Operative Wound Infection (2446)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Pulat akin sabanci, tugrul cem unal, onur ozturk, duygu dolen, ilyas dolas, baris peker, esra saka, achmet ali, aydin aydoseli, yavuz aras, altay sencer, kemal hepgul, nail izgi, orhan barlas.Effect of intraoperative computed tomography on ventriculoperitoneal shunt survival.World neurosurgery (2021).Doi: 10.1016/j.Wneu.2021.06.106 background: in patients with hydrocephalus who undergo ventriculoperitoneal shunt placement, the ventricular catheter tip position is one of the most important prognostic factors influencing shunt survival.The aim of this study was to present our findings of ventriculoperitoneal shunt placement performed with intraoperative computed tomography (ct) and to evaluate the effect of intraoperative ct-based image guidance on optimal catheter positioning and overall shunt survival.Methods: of the study enrolled 345 patients with hydrocephalus who underwent ventriculoperitoneal shunt placement for the first time between 2008 and 2018.Ventricular catheters were inserted freehand via the kocher point into the lateral ventricle in all patients.In 163 patients, intraoperative ct was performed to confirm the tip position.In this group of patients, if the tip position was nonoptimal, the catheter was ejected and reinserted during the surgery.In the remaining 182 patients, the tip position was assessed with routine postoperative ct.The effect of performing intraoperative ct on catheter tip positioning and shunt failure was investigated.Results: nonoptimal tip position was significantly correlated with shunt dysfunction even when excluding nonobstructive causes (p <(><<)> 0.001).In the intraoperative ct group, 11 ventricular catheters (6.7%) were intraoperatively repositioned.The repositioning significantly improved the optimal tip position rate from 54% to 58.3% (p [ 0.007).Intraoperative ct usage also showed direct correlation with shunt survival (p [ 0.006).Conclusions: intraoperative ct is an effective tool for increasing the rate of optimal tip positioning and thereby overall shunt survival.Reported events - after the shunt surgery, 13 patients (3.8%) presented with wound infection, which was treated without any surgery, and 5 patients (1.4%) presented with de novo hemorrhage.No patient developed de novo neurological deficit.- shunt failure developed in 97 patients (28.1%), which necessitated a second surgery.While nonobstructive factors, such as infection, intraperitoneal pseudocyst, peritoneal tip malposition, and system disconnection, were documented in 21 patients (21.6%), most of the failures were associated with obstruction of the shunting system (78.4%).Shunt dysfunction was observed at a rate of 14.9% in patients with optimal tip placement and 41.5% in patients with nonoptimal tip position (p < 0.001).

• Brand Name: UNKNOWN STRATA 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: 12379121
• MDR Text Key: 268663452
• Report Number: 2021898-2021-00155
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• 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: 08/13/2021
• 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