MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN DELTA VALVE/SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number UNKNOWN-A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930); Post Operative Wound Infection (2446)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: unknown-s, serial/lot #: unknown.Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided.Please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided.Please note that this date is based off the date of publication of the article as the actual event date was not provided.If information is provided in the future, a supplemental report will be issued.

Event Description

Anthony azzolini <(>&<)> katie magoon <(>&<)> robin yang <(>&<)> scott bartlett <(>&<)> jordan swanson <(>&<)> jesse taylor.Ventricular shunt complications in patients undergoing posterior vault distraction osteogenesis.Child's nervous system 2019.Doi: 10.1007/ s00381-019-04403-w abstract purpose the primary objective of this study is to investigate post-operative morbidity and shunt revision rates of patients with shunt-dependent hydrocephalus (sdh) undergoing posterior vault distraction osteogenesis (pvdo) compared to patients undergoing conventional posterior vault reconstruction (pvr).Methods a retrospective case-controlled cohort analysis of all patients with sdh undergoing pvdo and pvr for syndromic or complex craniosynostosis was performed.Demographic information, perioperative variables, distraction protocols, and shunt related complications¿infection, surgical revision of shunt, increased length of stay (los), and readmission within 90 days of surgery¿were compared using the appropriate statistical tests.Results fourteen patients with ventricular shunts who underwent pvdo and eight patients with shunts who underwent pvr were identified.Shunt-related complication rates were significantly higher with pvdo (n = 5) compared to pvr (n = 0), p = 0.0093.Among the five patients who suffered complications, the most common were shunt infection (n = 4), shunt malfunction (n = 4), and wound infections (n = 3).All patients with complications required additional operations for shunt revision and/or replacement; four patients required multiple takebacks for such procedures, with an average of three additional procedures per patient.Conclusions in complex or syndromic craniosynostosis patients who have previously undergone ventricular shunting, pvdo is associated with higher shunt-related complications and need for additional procedures when compared to traditional pvr.While the benefits of pvdo in the treatment of syndromic craniosynostosis are well documented, the risks of pvdo in the face of a vp shunt must be considered.Further investigation into patient-specific risk factors and risk reduction strategies is warranted.Reported events: all of the patients who had complications (n = 5) were found to have more than one.In the sub-analysis of the patients who had complications, each of these five patients had multiple readmissions.In total, they accounted for 17 hospital readmissions.The most common complications were shunt malfunctions (n = 4, 80%) and shunt infections (n = 4, 80%).Other complications included wound infections (n = 3, 60%), prolonged csf leaks (n = 2, 40%), and wound dehiscence (n = 1, 20%).Further, of the patients with complications, two used a delta system and one used a strata system, while the remaining two patients had no documentation of their shunt type due to initial placement at an outside facility.Each of the five patients required a repeat operation for either shunt revision, externalization, or replacement.

• Brand Name: UNKNOWN DELTA VALVE/SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 9440350
• MDR Text Key: 186772732
• Report Number: 2021898-2019-00436
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-A
• Device Catalogue Number: UNKNOWN-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 4 YR