MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II SNAP SHUNT ASSEMBLY, SMALL; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 27816

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abnormal Blood Gases (1034); Bacterial Infection (1735); Cardiac Arrest (1762); Death (1802); Septic Shock (2068); Complaint, Ill-Defined (2331)

Event Date 05/12/2017

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient was prematurely delivered on (b)(6).It was stated the patient suffered a grade iv left sided intraventricular hemorrhage, giving way to hydrocephalus, which required a series of lumbar taps; a reservoir was placed (b)(6) 2017.The treating neurologist planned for the patient to receive a vp shunt when they reached (b)(6).They fought off several serious infections before they reached that goal.Despite the setbacks, the patient gained weight and reached (b)(6) on or about (b)(6) 2017.The treating neurologist determined that the vp shunt surgery could be performed, and the patient was implanted.According to the operative reports, the patient received a programmable valve with a snap reservoir dome.By the time several measures were taken to save the patient's life, they spiraled into metabolic acidosis and disseminated intravascular coagulopathy (dic).From the morning of the vp shunt surgery on (b)(6) 2017, the patient was constantly treated for many symptoms of the massive and fatal infection.The patient died after unsuccessful cpr efforts.The cause of death was stated as cardiac arrest due to septic shock due to vp shunt infection.The autopsy report isolated the gram-negative organism in the brain, and within the catheter of the shunt as serratia.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that there was history of maternal chorioamnionitis and presumed neonatal meningitis.Serial ultrasounds demonstrated grade iv intraventricular hemorrhage with increasing hydrocephalus.Ultrasound on (b)(6) 2017 noted significant increase in ventricular dilatation with residual blood products in both lateral ventricles.On (b)(6) 2017, a right frontal insertion of ventricular catheter with subcutaneous reservoir was placed when the infant reached a weight of (b)(6), to help periodically drain csf.There were no complications and the baby was in stable condition after the procedure.On (b)(6) 2017, when the infant wight was above 2500 grams, the right frontal ventricular catheter reservoir was removed and a ventriculoperitoneal shunt was placed.Again there were no complications and the baby tolerated the procedure well.Not long after the ventriculoperitoneal shunt placement, cultures of the csf from a shunt tap (collected (b)(6) 2017) grew gram negative bacilli, specifically serratia marcescens, consistent with vp shunt infection.He was given broad spectrum antibiotics, neupogen and ivig; however, he continued to have worsening neutropenia and metabolic acidosis.He went into cardiac arrest and resuscitation efforts were initiated.However, given the critical status resuscitation was stopped and the baby passed away on (b)(6) 2017.The autopsy summary stated that a specific source for the infection was not entirely clear, given there were multiple possible primary sites.Postmortem examination of the gi tract showed no evidence of perforation, necrosis or enterocolitis, but approximately 40cc of serosanguinous peritoneal fluid was removed and cultures of peritoneal fluid grew serratia marcescens.Histologic sections of the brain showed a focal area of gram negative bacilli and cultures of csf fluid grew serratia marcescens.Histologic sections of the lungs showed features of acute damage, including alveolar hemorrhage, fibrinous material within alveolar spaces and focal hyaline membranes, as well as gram negative bacilli within alveolar spaces.No postmortem lung cultures were performed, but it was presumed the gram negative bacilli were likely serratia marcescens given the other findings.The cause of death was most likely respiratory insufficiency complicated by premature birth with very low birth weight, hydrocephalus with vp shunt infection and pulmonary infection with alveolar damage.

• Brand Name: STRATA II SNAP SHUNT ASSEMBLY, SMALL
• 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, MN 92618 ; 7635263305
• MDR Report Key: 8625868
• MDR Text Key: 145594679
• Report Number: 2021898-2019-00188
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169010529
• UDI-Public: 00643169010529
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

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 Expiration Date: 03/31/2019
• Device Model Number: 27816
• Device Catalogue Number: 27816
• Device Lot Number: E11577
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 05/20/2019
• Supplement Dates Manufacturer Received: 09/19/2019
• Supplement Dates FDA Received: 10/14/2019
• Date Device Manufactured: 05/16/2016
• 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): Death
• Patient Age: 2 MO
• Patient Weight: 3