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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); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Wound Dehiscence (1154); Hematoma (1884); Intracranial Hemorrhage (1891); Unspecified Infection (1930); Pneumonia (2011); Urinary Tract Infection (2120); Post Operative Wound Infection (2446); Respiratory Failure (2484); Convulsion/Seizure (4406); Unspecified Nervous System Problem (4426); Respiratory Insufficiency (4462)
Event Date 10/31/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Nadia mansoor <(>&<)> ole solheim <(>&<)> oddrun a. Fredriksli <(>&<)> sasha gulati. Revision and complication rates in adult shunt surgery: a single-institution study. Acta neurochirurgica 163 (2021). Doi: 10. 1007/s00701-020-04526-z abstract background csf diversion with shunt placement is frequently associated with need for later revisions as well as surgical complications. We sought to review revision and complication rates following ventriculoperitoneal, ventriculoatrial and cystoperitoneal shunt p lacement in adult patients, and to identify potential risk factors for revision surgery and postoperative complications. Method included patients were adults (
=
18 years) who underwent primary shunt insertion at st. Olavs hospital in trondheim, norway, from 2008 through 2017. The electronic medical records and diagnostic imaging from all hospitals in our catchment area were retrospectively reviewed. Follow-up ranged from 1 to 11 years. Complications were graded according to the landriel ibañez classification system. Results of the 227 patients included, 47 patients (20. 7%) required revision surgery during the follow-up. In total, 90 revision surgeries were performed during follow-up. The most common cause for the first revision was infection (5. 7%) and for all revisions proximal occlusion (30. 0%). A total of 103 patients (45. 4%) experienced
=
1 complication(s). Mild to moderate complications (grade i and ii) were detected in 35. 0% of all procedures. Severe or fatal complications (grade iii and iv) were observed in 8. 2% of all procedures. Urinary tract infections and pneumonia were common postoperatively (13. 9% and 7. 3%, respectively), and the most common iib complication was shunt misplacement (proximally or distally). Two out of fourteen deaths within 30 days were directly associated with surgery. We did not find that aetiology/indication, age or gender influenced the occurrence of revision surgery or a grade iii or iv complication. Conclusions shunt surgery continues to be a challenge both in terms of revision rates and procedure-related complications. However, the prediction of patients at risk remains difficult. A multidimensional focus is probably needed to reduce risks. Reported events. - a total of 47 patients (20. 7%) underwent a revision surgery at some point during the follow-up period. Thirty-two patients (14. 1%) required their first revision surgery within 1 year from index surgery. Twenty patients (8. 8%) underwent revision surgery more than 1 year after index surgery, either as a first revision or subsequent revision (revision surgery falling between > 1 year from index surgery and through 2018). The most common cause of overall revision surgery was due to proximal failure/occlusion, accounting for 30. 0% of revisions. Infection was the second most common cause for overall revisions, accounting for 21. 1%. Misplacement accounted for the third most common cause for overall revisions with 14. 4%. The ia medical complications were exclusively cases of urinary retention. Surgical ia complications consisted mainly of subdural effusion/subdural haematoma, managed conservatively, and two cases of new transient neurological deficits. Uti and pneumonia accounted for most of the ib medical complications. Surgical ib complications consisted of one wound infection requiring antibiotics only, and one patient with post-surgical seizures requiring anticonvulsants. The medical iia complications were mainly patients with pleural effusions, requiring drainage. The surgical iia complications consisted of one case of a dehiscent wound, requiring surgical closure under local anaesthesia, one patient requiring additional lumbar drainage and one case requiring temporary external drainage. Three cases of medical iib complications were detected¿pneumonia-causing atelectasis and requiring bronchoscopy in two patients and one patient suffering from an acute haemorrhage after undergoing tracheostomy, requiring intervention. The most common cause of surgical iib complications was hardware misplacement (either proximally or distally), requiring reoperation. There were also five cases of track haematomas causing dysfunctional ventricular catheters, requiring revisions surgeries. Grade iiia surgical complications consisted mainly of patients with csf infection, verified by csf specimens, requiring surgery with either externalisation or removal of the shunt. Four patients were re-intubated after surgery due to respiratory distress and respiratory failure and were classified as medical iiia complications.
 
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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 Key11806898
MDR Text Key264780040
Report Number2021898-2021-00108
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeNO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2021
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 Received04/28/2021
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: 05/11/2021 Patient Sequence Number: 1
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