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 Problem Death (1802)

Event Type  Death  

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: 3004608878-2019-01030, 3004608878-2019-01031, and 3004608878-2019-01032.Doi: https://doi.Org/10.1055/s-0038-1676597.

Event Description

This is 4 of 4 reports.The journal of neurological surgery (2019) published "frame-based stereotactic biopsy: description and association of anatomical, radiologic, and surgical variables with diagnostic yield in a series of 407 cases".Stereotactic biopsy is a versatile, minimally invasive technique to obtain tissue safely from intracranial lesions for their histologic diagnosis and therapeutic management.The objective of the study was to determine the anatomical, radiologic, and technical factors that can affect the diagnostic yield of this technique.Methods: this retrospective study evaluated 407 patients who underwent stereotactic biopsies in the past 34 years between 1982, when this technique was first used in their institution, and 2016 were retrieved and evaluated.The surgical methodology changed through time, distinguished by three distinct periods.The surgical methodology used throughout the decades was determined by the equipment available in the hospital at the time.Different stereotactic frames, neuroimaging tests, and planning programs were used.During period 1 (1982-1991), todd-wells (radionics) was used; period 2 (1991-2011), cosman-roberts-wells (crw) (integra) along with the nashold biopsy needle (integra) were used; and period 3 (2011-2016) leksell (electra instruments) was used.Statistical analysis was performed with spss v.23 for windows (spss inc.) using parametric tests.The 407 patients who had undergone stereotactic biopsy in department, 143 in period 1 (35.2%), 213 in period 2 (52.3%), and 51 in period 3 (12.5%).The average age of the patients in the series was 53.8 years.Most of the patients were in the fifth and sixth decades of life (47.6%), with an average of 57 years of age (range 3-86 years old).Fourteen (3.4%) were pediatric (patients 16 years of age).The sex ratio was 1.8:1, with 265 men (65.1%) and 142 women (34.9%).Most lesions were on the left side (41.8%).The frontal region was the most frequently biopsied anatomical region (24.8%), and the cerebellum (1%) and brainstem (1%) were the least.After histologic evaluation, the most frequently diagnosed pathologies were tumor in 78.8%, followed by vascular pathology (i.E., hemorrhagic or ischemic stroke) in 5.4%, radionecrosis in 0.5%, and neurologic pathology (multiple sclerosis) in 0.2%.The most frequently diagnosed tumor was a high-grade glioma (42.8%); the biopsies were nondiagnostic in 9.6%.Forty patients (9.8%) had symptomatic intracranial hemorrhages (worsened the level of consciousness and/or produced new neurologic deficits after the biopsy).Most of those patients improved significantly in the following days.Twenty-three of the patients (57.5%) were discharged with a karnofsky performance status greater than 80.During period 2, hemorrhagic complications: karnofsky performance status less than or equal to 70 at discharge was 8.Morbidity was 5.65% (n = 17).The procedure-associated mortality was 0.98% (n = 4).During period 2, mortality was 1.The overall diagnostic yield of our stereotactic biopsies was 90.4%, and there were no statistically significant differences in the diagnostic yields among the three methodological periods (p = 0.864).Intraoperative biopsy improved accuracy (p = 0.024).Biopsies of deep lesions (p = 0.043), without contrast enhancement (p = 0.004), edema (p = 0.036), extensive necrosis (p = 0.028), or a large cystic component (p = 0.023) resulted in a worse diagnostic yield.Neurosurgeons inexperienced in stereotactic techniques obtained more nondiagnostic biopsies (p = 0.043).Experience was the clearest predictive factor of diagnostic yield (odds ratio: 4.049).Overall, 39 of the biopsies (9.6%) were nondiagnostic.This result was consistent with previous reports.Of those, 2% (n = 8) were inconclusive, and 7.6% (n = 31) were negative.In these patients, the stereotactic biopsy was repeated once in 71.7% of the cases (n = 28) and twice in 10.2% of the cases (n = 4).In this series of 407 patients, 82 (20.1%) underwent craniotomies after the biopsy.The main reasons were either surgical resection of the lesion was considered the best treatment strategy after histologic results (64.7%; n = 53) or there were doubts about these histologic results because of the clinical condition and the neuroimaging tests of the patient (26.8%; n = 22).In seven patients (8.5%), the indication for surgery was based on not obtaining a diagnosis by stereotactic methods.Conclusion: increased experience in stereotactic techniques, use of the most suitable magnetic resonance imaging sequences during biopsy planning, and intraoperative evaluation of the sample before finalizing the collection are recommended features and ways to improve the diagnostic yield of this technique.

Manufacturer Narrative

Additional information received on (b)(6) 2019 from the author indicating that "neither deaths nor ae were associated with integra lifesciences products.".

Event Description

N/a.

Manufacturer Narrative

The device was not returned for evaluation.The device history record review was not performed; the lot number and serial numbers has not been provided.A failure analysis and root cause determination cannot be completed due to the lack of information received.The complaint was created from a literature article.The product was not returned.The reported complaint is unconfirmed.

Event Description

N/a.

• 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: 9136906
• MDR Text Key: 160691003
• Report Number: 3004608878-2019-01033
• 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,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: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death