MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR UNKNOWN PUDENZ VALVE; N/A

Catalog Number XXX-PUDENZ

Device Problem Product Quality Problem (1506)

Patient Problems Unspecified Infection (1930); Injury (2348); Meningitis (2389)

Event Type  Injury  

Manufacturer Narrative

No complaint unit will be returned and no failure analysis is possible since this complaint correspond to a retrospective review from 2009 to 2011.Based on the absence of lot and catalog information of the products used, it is not possible to identify the manufacturing time frame to be reviewed and, therefore, it was not possible to perform the dhr review and event/nc/capa/scar history review.The reported conditions are unconfirmed.The root cause of the reported conditions are undetermined.(b)(4).Doi: 10.12809/hkmj154735.

Event Description

Hong kong medical journal (2016) published "primary ventriculoperitoneal shunting outcomes: a multicenter clinical audit for shunt infection and its risk factors.The objective was to determine the frequency of primary ventriculoperitoneal shunt infection among patients treated at neurosurgical centres and to identify underlying risk factors.Methods: the multicentre historical cohort study included consecutive patients who underwent primary ventriculoperitoneal shunting at a neurosurgery centre from 01jan2009 to 31dec2011.The primary endpoint was shunt infection.Secondary endpoints were shunt malfunction, defined as unsatisfactory cerebrospinal fluid drainage that required shunt reinsertion, and 30-day mortality.All subjects were followed up for at least 30 days from the operation date or until death.The mean (+/-standard deviation) age of patients was 48 +/- 13 years (range, 13-88 years) and the male-to-female ratio was 1:1.In the study group, 80 (15%) were pediatric patients and 48 (9%) were infants.Overall, primary vp shunting was performed for post-aneurysmal subarachnoid hemorrhage communicating hydrocephalus in 169 (31%) patients, for cns neoplasms in 164 (30%) patients, and for spontaneous intracerebral or intraventricular hemorrhage in 64 (12%) patients.Almost three quarters of vp shunts had a fixed pressure valve (n=390, 72%) and the predominant design utilized was the integra pudenz flushing valve in 324 (60%) patients.Results: the rate of vp shunt reinsertion was 16% (n=87) and infection was 7% (n=36).The main causes for reinsertion were malfunction (9%) followed by infection.Most infections manifested as meningitis or ventriculitis (n=19, 53%), followed by wound breakdown (n=15, 42%) and peritonitis (n=2, 6%).The most common causative bacteria were coagulase-negative staphylococci (cons) [n=25, 69%] of which methicillin resistance was detected in 19 (76%) patients.The second most common infective agent affecting four (11%) patients was mr staphylococcus aureus (mrsa).Polymicrobial infection was evident in six (17%) patients.One patient with peritonitis had mixed gram-positive and -negative microorganisms from csf cultures.In this study, 30-day all-cause mortality was 6% (n=32), but none was directly procedure related.Almost half of these patients (n=15, 47%) had an underlying malignant cns tumour; the majority being brain metastases.Conclusion: this is the first hong kong territory-wide review of infection in primary ventriculoperitoneal shunts.Although the ventriculoperitoneal shunt infection rate met international standards, there are areas of improvement such as vancomycin administration and the avoidance of scheduling the procedure as an emergency.

• Brand Name: UNKNOWN PUDENZ VALVE
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8235048
• MDR Text Key: 132911931
• Report Number: 2648988-2018-00065
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K153041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-PUDENZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 01/10/2019
• 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