MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S. A. CHPV; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Device Problems Excess Flow or Over-Infusion (1311); Device Issue (2379)

Patient Problem Unspecified Infection (1930)

Event Date 07/31/2015

Event Type  Injury  

Manufacturer Narrative

It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.

Event Description

The literature article "role of ventriculoperitoneal shunt valve design in the treatment of pediatric hydrocephalus" - a single center study of valve performance in the clinical setting�published childs nerv syst (2014) 30:293-297 doi 10.1007/s00381-013-2244-z, states that post chpv implantation 15 patients experienced shunt failure requiring reoperation.The aim of this study was to compare the fixed-pressure non-codman valves and the programmable codman hakim valves in the clinical setting.A retrospective review of 102 patients younger than 16 years who underwent primary implantation of a ventriculoperitoneal shunt with either valve type at our institution between january 2005 and december 2010 was conducted.The codman hakim cohort comprised 29 patients, of which 55 % (15) experienced shunt failure with a mean time to shunt failure of 8 months.Shunt failure was defined as a malfunction making reoperation necessary.Stratified analyses identified young age at implantation and post hemorrhagic hydrocephalus as risk factors for shunt failure.Shunt survival analysis revealed no significant difference with regard to valve type.There were no shunt-related deaths in the either of the cohorts.In the codman hakim cohort, the mean age on implantation was 70 months (1-180 months), with 4 patients being =12 months of age, 11 patients being between 13 and 60 month, and 13 patients being >60 months.Indications for shunt implantation were tumor in 13 (45 %), hemorrhage in 4 (14 %), malformation in 8 (28 %), and others including posttraumatic and post infectious hydrocephalus in 4 patients (13 %), respectively.Sixteen patients (55 %) reached the endpoint of shunt failure.The mean time until shunt failure was 8 months (0-42 months).Reason for shunt failure was mechanical in 10 (59 %), infectious in 4 (24 %), and functional in 2 patients (12 %), respectively.Again, overdrainage was responsible for both cases of functional shunt failure.In the chpv cohort, two patients died from non-device related tumor progression.At the time of the complaint entry, the complaint devices were not available for analysis and no sterile lot numbers were reported.

• Brand Name: CHPV
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S. A.; rue girardet 29; ch-2400 le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5114239
• MDR Text Key: 27146125
• Report Number: 1226348-2015-10561
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Other

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• 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: 09/08/2015
• 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