MAUDE Adverse Event Report: UNK HAKIM PRECISION VALVE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

Udi: unknown product code, udi unavailable.Upon completion of the investigation, a follow up report will be filed.

Event Description

In the flash presentation fp094 at ¿25th congress of the european society for pediatric neurosurgery (espn) paris-france, 8-11 may 2016¿ titled ¿survival of gravitational versus traditional nongravitational valves after primary ventriculoperitoneal shunt insertion in children: a retrospective cohort study ¿, published childs nerv syst (2016) 32:905¿1012 doi 10.1007/s00381-016-3044-z, it was reported that 55 shunt failures post implantation of unknown codman hakim precision valves.Per the article: ¿introduction: gravitational valves -designed to reduce overdrainage by preventing siphoning- are increasingly being used for primary shunts in children.This long-term theoretical advantage is tempered by the suspicion that more complex valve designs are more prone to early failure.Methods: retrospective cohort study, examining all primary shunts -either gravitational valve (gv; miethke paedigav) or non-gravitational valve (ngv; codman precision) inserted at our institution during the study period 2007-2014.Early failure was defined as need for shunt revision within 30 days of primary surgery.Late failure was defined as need for shunt revision at any point following 30 days.Chi square statistical analysis was used to compare groups.Results: 207 primary shunts were inserted during the study period -36 gv and 171 ngv.Mean age of the gv group was 262 days against 783 days in ngv group.The diagnosis profile differed between the 2 groups, with post-hemorrhagic and dysraphism-associated hydrocephalus proportionally more common in the gv group and tumor-associated hydrocephalus more common in ngv group.There were 5 early failures in the gv group and 10 in the ngv group.For late failures, there were 4 events in the gv group with 45 in the ngv group.Conclusions: the overall 1 year survival was almost identical between the 2 groups, although there was a trend for more early failures in the gv group which was balanced by less late failures.In line with previous studies, there is little evidence currently to suggest superiority of one valve choice over another for primary shunts in children.¿ at the time of complaint entry no device specific information, i.E.Catalogue/lot number, is available.

Manufacturer Narrative

It was initially reported that the device would be returned for evaluation.However, multiple attempts to obtain the sample were not successful.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman and no lot or product number information was 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.Complaint will be closed at this time as 'no complaint sample returned to codman for evaluation'.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: UNK HAKIM PRECISION VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6431940
• MDR Text Key: 70809012
• Report Number: 1226348-2017-10181
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention