MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CRW SYSTEM; STEREOTAXY

Catalog Number XXX-CRW

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

Patient Problems Hematoma (1884); Seizures (2063)

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Doi: 10.4103/ajns.Ajns_137_18.

Event Description

Asian journal of neurosurgery (2019) published ¿venture in 101 cranial punctures: a comparative study between frame-based versus frameless biopsy of 101 intracranial space occupying lesion¿.Presumptive diagnosis based solely on the clinical picture and imaging was not sufficient to provide appropriate treatment with certainty and hence histopathological confirmation of intracranial space occupying lesion (icsol) is essential.Needle biopsy via stereotactic frame-based or frameless neuronavigation technique was efficient procedure.The objective of the study was to compare their accuracy and efficacy and safety.Methods: this was a single-center retrospective analytical cross-sectional nonprobability purposive study conducted in the center among 101 patients during a period of 5 years from 2014 to 2018.Two techniques were used: frame-based stereotactic using the cosman-robert-wells (crw) frame; and frameless neuronavigation-guided in which image acquisition was done from magnetic resonance imaging image loaded compact disc and patient registered in stealth, neuronavigation system, an infrared led-based system.Head of patient was shaved after general anesthesia and head fixed with three pins clamp on mayfield.A biopsy was done by dedicated neurosurgeons.The selection of technique was based on the surgeon preference.Results: out of 101 patients, frame-based stereotactic biopsy was done among 55 patients (54.4%) while 46 patients (45.6%) underwent frameless stealth neuronavigation guided biopsy.Male to female ratio was 2.1:1.Age ranged from 5 to 82 years.54.5% (55 patients) have deeper location of tumor while 45.5% (46 patients) have lobar location of tumor.Frontal (16.8%) and thalamic (13.8%) were the common site.Mean size of tumor was 3.0 +/- 0.85cms.There was statistically significant difference in operative duration among study groups.Overall diagnostic yield was 89.1%.Glioma was the most common (50.5%) diagnosis.Glioblastoma who grade iv was 37.6% followed by lymphoma (12.8%).Overall, postoperative morbidity was 4.9%.Two patients developed seizure among frame-based stereotactic group while tract hematoma was present in one case of each study group which were managed conservatively.One patient in frameless neuronavigation group developed neurological deficit.The mean duration of hospital stay was 11.83 +/- 10.13 days (range: 4¿42 days).There was no mortality in any groups.In a study done by kreth et al., 0.9% developed hemorrhage-related complication.As reported by krieger et al.Of 3500 stereotactic biopsies, they had one procedure-related death, seven significant hemorrhages including subdural and epidural hematomas, five seizures (1.4%), and two infections.Conclusion: needle biopsy through frameless or frame-based technique is a safe and efficient procedure.Both techniques have a high diagnostic yield.Reasons for negative biopsy were missed target or retrieval of gliotic tissue from the target lesion.High-volume prospective study is recommended to attest these inferences.

Event Description

N/a.

Manufacturer Narrative

Root cause cannot be determined due to the lack of information received to perform a complete investigation.Product will not be returned for evaluation.This complaint will be closed in accordance with the integra lifesciences complaint process.The reported complaint is unconfirmed.

• Brand Name: CRW SYSTEM
• Type of Device: STEREOTAXY
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 9135948
• MDR Text Key: 166412380
• Report Number: 3004608878-2019-01019
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K944463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-CRW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: MAYFIELD