PubMed · 8325472
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E Petz. 1993. [Pacemaker substitution].. https://pubmed.ncbi.nlm.nih.gov/8325472/
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BACKGROUND: Whereas there are case reports of laparoscopy in patients with ventriculoperitoneal shunts, there are no studies assessing the potential failure of shunt valves with the increased intra-abdominal pressure of laparoscopy. This study aims to assess this factor. METHODS: An in vitro model was used to assess the potential for retrograde failure of ventriculoperitoneal shunt valves in a commonly used shunt. Nine shunts were subjected to graded increases in back pressure and observed for retrograde valve leak. RESULTS: None of the shunts tested showed any signs of leak associated with the increased back pressure. However, disruption of shunt seals was noted in seven of the nine shunts, occurring at the minimal pressure of 80 mmHg. CONCLUSIONS: There appears to be minimal risk of retrograde failure of the valve system in the ventriculoperitoneal shunt tested. However, tests on different types of ventriculoperitoneal shunts would be needed to confirm these results if laparoscopy is to be considered safe in patients with ventriculoperitoneal shunts in situ.
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In France the manufacturer, the user of a medical device and all those informed of an event or a risk for an event caused by the device and resulting in death or the deterioration of the health status of a patient must declare the event without delay to the appropriate administrative authority. The witness of the event informs either the local correspondent for materiovigilance, when available, or the ministry directly. A major objective of the local correspondent is to act as a filter and to select among the declarations of events those to be transmitted without delay or quarterly to the ministry, and those to be registered only locally. Within 48 hours the ministry: a) returns an acknowledgement with instructions how to proceed with the involved device; b) communicates the declaration to the chairman of the ad hoc subcommission; c) informs the manufacturer of the device. The chairman decides on the degree severity (major event requiring an immediate investigation, event requiring an investigation, event to be entered in a follow-up programme). In the first two cases an investigation is undertaken by one or several members of the subcommission in co-operation with the manufacturer and the declarant of the event. Conservative measures can be undertaken to prevent the re-occurrence of an event either with the involved and/or with similar devices and to facilitate the investigation.