MAUDE Adverse Event Report: VENT RES TR SAL-RIC ST BA; RESERVOIRS

Catalog Number 821625

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

Patient Problem Unspecified Infection (1930)

Event Date 06/29/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

Clinical study: the patient was implanted on (b)(6) 2017 with a codman holter salmon rickham (lot-number: 134223; device serial number: (b)(4)).The subject is a (b)(6) year-old female with mucopolysaccharidosis type iiib enrolled in: "a multicenter, multinational, extension study to evaluate the long-term safety and efficacy of intracerebroventricular ax 250 in patients with mucopolysaccharidosis type iiib (mps iiib, sanfilippo syndrome type b)".Study treatment with ax 250 was initiated on (b)(6) 2018.The subject's most recent dose of ax 250, received prior to the sae/eosi onset, was on (b)(6) 2021.The subject's relevant medical and surgical history included recurrent rhinitis, abnormal facial features, short neck, hepatomegaly, and recurrent diarrhea.Relevant concomitant medications taken within 14 days of sae onset included paracetamol and cetirizine.Previously reported sae/eosis for this subject included pyrexia (fever (max 38.0°c)) on 27-jul-2017 (17-de-ax201-00054) , csf leakage on 27-jul-2017 (17-de-ax201-00056), vomiting on 28-jul-2017 (17-de-ax201-00060), csf pleocytosis on 19-oct-2017 (17-de-ax201-00083) , csf pleocytosis on 26-oct-2017 (17-de-ax201-00085), headache on 02-nov-2017 (17-de-ax201-00089) , diarrhea (viral infection) on 18-oct-2017 (17-de-ax201-00091), adverse drug reaction (headache, fever) on 25-oct-2017 (17-de-ax201-00093) , adverse drug reaction (vomiting, fever, exanthema) on 18-oct-2017 (17-de-ax201-00095) , vomiting on 20-dec-2017 (17-de-ax201-00098) , csf pleocytosis (max 544/3 cells) on 28-jul-2017 (17-de-ax201-00102) and csf pleocytosis on 03-nov-2017 (17-de-ax201-00133).On (b)(6) 2021, the subject presented to the emergency room for the scheduled intracerebroventricular injection (icv) in good health.When the cerebrospinal fluid (csf) was aspirated, it appeared flaky.The csf microscopy revealed, leukocytes 25 microliters and gram-positive cocci.An important medical event of suspicion of icv infection was reported.A csf culture was collected for which the results are awaited.However, no clinical signs of ventriculitis were observed.A csf follow up was planned.The event was ongoing.The investigator assessed the suspicion of icv infection as nci ctcae grade 2 in severity and not related to study drug.The investigator assessed the suspicion of icv infection as related to the non-study device the patient had a codman holter salmon rickham implanted.The csf culture identified staphylococcus epidermidis.On (b)(6) 2021, icv puncture was performed, and the csf was found to be cloudy.The reservoir was blocked with 10mg vancomycin.The subject was still asymptomatic and in a good clinical condition.Blood count and chemistry was normal without signs of inflammation.The subject was admitted to the hospital and intravenous (iv) vancomycin 600mg was started.After 30 minutes she developed an allergic reaction (flush, urticaria) and the vancomycin infusion was stopped.After an anti-allergic therapy with prednisolone 100 mg iv and clemastine (tavegil) 1.5 mg iv the subject recovered quickly.The antibiotic therapy was switched to flucloxacillin iv and continued until (b)(6) 2021.During the admission, the subject was without any symptoms.On (b)(6) 2021, the reservoir was explanted without any complications.The subject was administered propofol 100 mg once, sufentanil 7.5 microgram once, dexamethasone 4 mg once, rocuronium (esmeron) 20 mg once, ondansetron 3 mg once and sterofundin 500 ml once for the explantation.On (b)(6) 2021, a cerebral magnetic resonance imaging (mri) for planning the rickham reservoir re-implantation was done.On (b)(6) 2021, the event was considered resolved and the subject was discharged in a good condition.The re-implantation was scheduled for (b)(6) 2021.The investigator assessed the icv infection as nci ctcae grade 3 in severity (previously reported as grade 2) and not related to study drug.The investigator assessed the icv infection as related to the non-study device.Protocol mandated procedure of icv puncture and study drug administration was assessed as possible non-product cause of the event.The sponsor assessed the icv infection of nci ctcae grade 3 as not related to study drug.The sponsor assessed the icv infection as related to the non-study device.The sae term was updated to icv infection (previously reported as suspicion of icv infection).

Event Description

N/a.

Manufacturer Narrative

Additional information received: the rickham-reservoir was explanted due to the event of icv infection.The investigator assessed the icv infection as nci ctcae grade 3 in severity (previously reported as grade 2) and not related to study drug.The investigator assessed the icv infection as related to the non-study device.The sponsor assessed the icv infection of nci ctcae grade 3 as not related to study drug.The sponsor assessed the icv.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 sample was returned for evaluation: dhr - lot 134223 conformed to the specifications when released to stock failure analysis - the rickham and catheter were visually inspected; needle holes and tears/cuts were noted in the rickham and in the catheter a small cut/tear over the metal connector was noted.-the rickham and catheter were irrigated no occlusions noted.-the valve was leak tested: leaks were noted in the rickham no leaks noted with the catheter.-a review of the sterilization certificate was conformed to specifications when released.Root cause - the root cause for the needle holes tears/cuts in the rickham is due to users¿ error, as noted in the ifu: to inhibit coring of the reservoir cap a huber point needle (24- or 26- gauge) should be used to penetrate the dome.The possible root cause for the infection issue reported by the customer, could be linked to the patient and hospital surroundings as the sterilization certificate was conformed and within specifications.

Event Description

N/a.

• Brand Name: VENT RES TR SAL-RIC ST BA
• Type of Device: RESERVOIRS
• MDR Report Key: 12216731
• MDR Text Key: 267671802
• Report Number: 3013886523-2021-00327
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 821625
• Device Lot Number: 134223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2017
• 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