MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR UNKNOWN CERTAS PLUS VALVE

Catalog Number XXX-CERTAS PLUS VALVE

Device Problem Pressure Problem (3012)

Patient Problems Hydrocephalus (3272); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

1 of 2 reports.Other mfg report number: 3013886523-2021-00550.Interdisciplinary neurosurgery: advanced techniques and case management 26 (2021) published: "category-2 shunt valve marketed as mri-conditional malfunction following routine 3 t magnetic resonance imaging" case description: "the patient is a (b)(6) woman with a history of posterior fossa medulloblastoma, who underwent surgical resection of this tumor in 2017.Following tumor resection, she developed hydrocephalus, for which she underwent ventriculoperitoneal shunt (vps) placement with the category-2 shunt valve marketed as mri-conditional.She underwent follow-up brain mri that was performed at 1.5 tesla, and in accordance with valve manufacturer guidelines.The following morning, her mental status declined and eeg demonstrated left hemisphere rhythmic delta activity, for which she was loaded with antiepileptic medications.Head ct demonstrated evidence of hydrocephalus with transependymal csf flow.Vps series showed the category-2 shunt valve marketed as mri-conditional (certas plus) at a setting of 7.0, in contrast to her prior setting of 4.0.An emergent vps revision was performed, at which time the valve was replaced." malfunction: failure to maintain programmed pressure setting (unintended pressure setting change).Conclusions: "in this case, we present a patient with a shunt valve that is marketed as designed to minimize the unintended setting changes from magnetic interference 3 t mri, which demonstrated evidence of unexpected setting change with inability to externally adjust following routine mri.Within 48 h of mri, she had developed symptoms of elevated intracranial pressure for which she required emergent surgical shunt revision.This case demonstrates the necessity of constant vigilance of possible valve complications, regardless of reported product features.Monitoring valve function closely can avoid potentially fatal malfunctions when detected early." https://doi.Org/10.1016/j.Inat.2021.101355.

Manufacturer Narrative

The certas valve was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined; however, the most probable root cause is most likely attributable to the underlying health conditions of the patients within the study.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: UNKNOWN CERTAS PLUS VALVE
• Type of Device: CERTAS PLUS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12965011
• MDR Text Key: 289672216
• Report Number: 3013886523-2021-00549
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XXX-CERTAS PLUS VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 11/15/2022
• Supplement Dates FDA Received: 12/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1