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 Hemorrhage, Cerebral (1889); Neurological Deficit/Dysfunction (1982); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device is not expected to be 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.Linked to mfg.Report numbers: 3004608878-2019-01034, 3004608878-2019-01035, and 3004608878-2019-01037.(b)(4).

Event Description

This is 3 of 4 reports.Clinical neurology and neurosurgery (2017) published "how is stereotactic brain biopsy evolving? a multicentric analysis of a series of 421 cases treated in rome over the last sixteen years".Objective: in recent decades, frame-based (fbb) and frame-less stereotactic brain biopsy (flb) have played a crucial role in defining the diagnosis and management of expanding intracranial lesions in critical areas.During the same period, there have been significant advances in diagnostic imaging, a shift in surgical strategies towards extensive resection in gliomas and new molecular classification of brain tumors.Taking these advances into account, the authors have evaluated whether significant changes have occurred over the last sixteen years of their clinical practice in terms of frequency, indications, target selection, and the histologic results of stereotactic brain biopsy (sbb) procedures.Patients and methods: they analyzed a series of 421 sbb cases treated between january 2002 and june 2017 in three major neurosurgical institutes in rome, serving a total of 1.5 million people.Within this series, 94.8% of patients underwent fbb using the cosman-roberts-wells (crw ¿ integra) stereotactic frame, while, more recently, flb was performed in 5.2% of cases using the stealthstation navigus frameless passive biopsy system (medtronic, inc.).All selected patients underwent stereotactic biopsy with a nashold needle through a standard burr hole.The entire period under consideration, running from 2002 to 2017, has been further stratified into four-year time-frames (2002¿2005, 2006¿2009, 2010¿2013, 2014¿2017) for the purpose of analysis.The median age of the patients was 63.5 (range 5¿82 years).216 were male and 205 were female.Results: the diagnostic yield was 97%.Final diagnoses revealed tumors in 90% of cases and non-neoplastic masses in 7%, while 3% of cases were not conclusive.Overall morbidity was 3% (13/421): transient neurological deficits occurred in 6 cases, while 7 patients suffered permanent deficits.Symptomatic cerebral hemorrhage requiring craniotomy occurred in six cases: three glioblastoma (gbm), two primary central nervous system lymphoma (pcnsl), and one abscess.Post-operative mortality rate, as a direct consequence of such hemorrhages after biopsy procedures, was 0.7% (3/421): one gbm, one lymphoma, and one abscess.Intra-operative frozen sections were made in 78% of biopsies.In our three institutes, the number of sbbs decreased steadily throughout the time-frames under consideration.They have also observed a statistically significant reduction in biopsy procedures in lobar lesions, while those performed on the basal ganglia increased and the number of sbbs of multiple masses and lesions of the corpus callosum remained stable.Primary central nervous system diagnosis of lymphomas (pcnsl) was the sole diagnosis whose incidence increased significantly.Conclusions: over the last sixteen years, we have witnessed a significant decrease in sbb procedures and a modification in target selection and histologic results.Despite the significant evolution of neuroimaging, an accurate non-invasive diagnosis of intracranial expanding lesions has not yet been achieved.Furthermore, the most recent who classification of brain tumors (2016), which incorporates molecular and morphological features, has boosted the need for molecular processing of tissue samples.

Event Description

N/a.

Manufacturer Narrative

The product was not returned for evaluation.The lot and serial numbers were not provided, therefore the dhr review cannot be performed.No new design or manufacturing trends were identified.A failure analysis and determination of root cause is not possible due to the lack of information received to perform a complete investigation although several requests for additional information were sent.The reported complaint is unconfirmed.Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(6) , director of regulatory programs, office of product evaluation and quality and (b)(6) , assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

• 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: 9136903
• MDR Text Key: 166546279
• Report Number: 3004608878-2019-01036
• 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

• 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
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 11/25/2019
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1