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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LLC STRATA II VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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COVIDIEN LLC STRATA II VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 42866
Device Problems Complete Blockage (1094); Infusion or Flow Problem (2964)
Patient Problems Intracranial Hemorrhage (1891); Coma (2417)
Event Date 12/22/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that before the shunt, the patient had an operation to remove a brain tumor (pilocytic astrocytoma), and an external lateral ventricular drain (evd) was placed on the right on (b)(6) 2020. On (b)(6) 2020, the drainage system was removed due to ventricular bleeding. Over the next 24 days, cerebrospinal fluid (csf) was repaired. There were no signs of infection in the csf during the whole period, and the patient received antibiotic-prophylactic. On (b)(6) 2020 the patient was implanted with a ventriculoperitoneal shunt without any complication. The valve performance was set at 2. The next day, the healthcare professionals (hcp) noticed signs of shunt insufficiency. The patient was experiencing drowsiness, and rising sun sign. Ct of the head showed a typical placement of ventricular catheter in the lateral ventricle with no signs of bleeding. The valve performance was reduced to 1 and then to 0. 5, but due to the lack of positive development, on (b)(6) 2020, a shunt revision was performed where a blockage with blood particles of the ventricular catheter was observed. It was stated that this was cleared up. After the operation, the hcp observed no positive development so a double shunt revision was fulfilled. As a result of the revision, it was found that the peritoneal and ventricular catheters were open. At that time, it was assumed that the shunt peritoneal catheter made a hook in the tunnel in which was corrected by stretching during the placement back of the catheter. Several hours later after the operation, signs of tentorium occlusion developed mostly on the left side (coma, expressed rising sun sign, 6th nerve function insufficiency). The valve performance was checked which was the same at 0. 5. Urgently, on (b)(6) 2020, an evd was placed on the left side. The shunt system has not been removed. Treatment has continued in the icu. The patient's condition has been assessed as severe during the last 2 weeks. Until (b)(6) 2021, the patient was on respiration with a low level of consciousness (coma, then sopor). The external drainage reservoir was located 10-12 cm above the external auditory canal; however, daily 400-450 ml accumulated in the reservoir. Positive dynamics was noticeable in the last 3 days. The patient opened their eyes, moved limbs, and followed some instructions. On (b)(6) 2021, an mri examination of the head was performed, and the results showed decreased ventriculomegaly, lack of continuous tumor growth but signs of hemorrhage on the left side of the midbrain as a result of the tentorium occlusion. Consultation with the neurosurgeons came to the conclusion that there was a problem with the valve.
 
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Brand NameSTRATA II VALVE, REGULAR
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
COVIDIEN LLC
15 hampshire street
mansfield 02048
Manufacturer (Section G)
COVIDIEN LLC
15 hampshire street
mansfield 02048
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key11178123
MDR Text Key227055598
Report Number9612501-2021-00085
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeAM
PMA/PMN Number
K042465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number42866
Device Catalogue Number42866
Device Lot Number0217254781
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 Received01/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/23/2019
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: 01/15/2021 Patient Sequence Number: 1
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