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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
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).
 
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Brand NameUNKNOWN STRATA VALVE/SHUNT
Type of DeviceSHUNT, 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 Key12379121
MDR Text Key268663452
Report Number2021898-2021-00155
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
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 Received08/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN-S
Device Catalogue NumberUNKNOWN-S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/27/2021 Patient Sequence Number: 1
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