BUDDE HALO RETRACTOR SYSTEM

Additional Manufacturer Narrative

IT IS UNKNOWN IF THE DEVICE WILL 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. DOI: HTTPS://DOI.ORG/10.1016/J.WNEU.2018.01.069.

Description of Event or Problem

WORLD NEUROSURGERY (2018) PUBLISHED "THE RADIOGRAPHIC EFFECTS OF SURGICAL APPROACH AND USE OF RETRACTORS ON THE BRAIN AFTER ANTERIOR CRANIAL FOSSA MENINGIOMA RESECTION" WHICH EVALUATED THE RADIOGRAPHIC CHANGES OVER TIME AFTER SURGICAL RESECTION OF ANTERIOR CRANIAL FOSSA MENINGIOMAS WITH AND WITHOUT BOTH SKULL BASE (SB) APPROACHES AND/OR FIXED RETRACTOR SYSTEMS. ALL ADULTS PATIENTS (AGE GREATER THAN 18 YEARS) UNDERGOING PRIMARY RESECTION OF AN ANTERIOR CRANIAL FOSSA WORLD HEALTH ORGANIZATION (WHO) GRADE I MENINGIOMA (OLFACTORY GROOVE, PLANUM SPHENOIDAL, "TUBERULUM" SELLA, AND CLINOID) THROUGH A CRANIOTOMY AT A SINGLE ACADEMIC TERTIARY-CARE INSTITUTION BETWEEN 2010 AND 2015 WERE RETROSPECTIVELY REVIEWED. TUMOR LOCATION WAS BASED ON PRE-OPERATIVE RADIOLOGY REPORTS AND ON THE ANTICIPATED TUMOR ORIGIN. THE CLINICAL, OPERATIVE, AND HOSPITAL COURSE OF RECORDS OF THE PATIENTS WHO MET THE INCLUSION CRITERIA WERE RETROSPECTIVELY REVIEWED. MAGNETIC RESONANCE IMAGING SCANS WERE TYPICALLY PERFORMED WITHIN 48 HOURS BEFORE SURGERY, 48 HOURS AFTER SURGERY, AND 3 AS WELL AS 9-12 MONTHS POSTOPERATIVELY. THE IMAGES WERE OBTAINED AND THE CHARACTERISTICS THAT WERE RECORDED INCLUDED THE PREOPERATIVE TUMOR (VOLUME CONTRAST ENHANCEMENT, EXCLUDING THE DURAL TAIL IF PRESENT) AND FLUID-ATTENUATED INVERSION RECOVERY (FLAIR) VOLUME (VOLUME OF FLAIR EXCLUDING THE TUMOR ENHANCING VOLUME) OF THE LESION, POSTOPERATIVE TUMOR AND FLAIR VOLUMES, POSTOPERATIVE PRESENCE OF ISCHEMIA (PRESENCE OF DIFFUSION-WEIGHTED HYPERINTENSITY AND ABSENCE OF HYPERINTENSITY ON APPARENT DIFFUSION COEFFICIENT TECHNIQUES), 3-MONTH POSTOPERATIVE TUMOR AND FLAIR VOLUMES. SB APPROACHES WERE DEFINED AS THOSE INVOLVING ORBITAL OSTEOTOMIES (ORBITOZYGOMATIC, MODIFIED ORBITOZYGOMATIC, TRANSZYGOMATIC, OR EXTENDED BIFRONTAL), WHEREAS THOSE INVOLVING ONLY DRILLING DOWN OF THE ORBITAL ROOF AS WELL AS ANTERIOR OR MIDDLE CRANIAL FOSSA WERE NOT CONSIDERED SB APPROACHES. THE USE OF A FIXED RETRACTOR SYSTEM (LEYLA, BRAUN; SYMMETRY SURGICAL, ANTIOCH; BUDDE, INTEGRA) WAS DETERMINED BASED ON OPERATIVE REPORTS. THE USE OF SB APPROACHES AND FIXED RETRACTOR SYSTEMS WAS BASED ON SURGEON PREFERENCE. WHEN FIXED RETRACTOR SYSTEMS WERE NOT USED, DYNAMIC RETRACTION WAS CHOSEN WITH THE USE OF HANDHELD INSTRUMENTS. RESULTS: THE AVERAGE AGE OF ALL PATIENTS WAS 55.9 +/- 11.7 YEARS AT THE TIME OF SURGERY, AND 39 (29%) WERE MALE. OF THE 136 TOTAL PATIENTS, 20 (15%), 12 (9%), 46 (34%), AND 58 (43%) UNDERWENT SB/RETRACTORLESS, SB/RA, NON-SB/RETRACTORLESS, AND NON-SB/RA SURGERY, RESPECTIVELY. PATIENTS WHO UNDERWENT NON-SB AND RA SURGERY EACH INDEPENDENTLY HAD LONGER TIMES TO FLAIR RESOLUTION THAN THOSE WHO UNDERWENT SB (20.9 VS. 5 MONTHS; P 0.04) AND RETRACTORLESS (12 VS. 5.2 MONTHS; P 0.02) SURGERY, RESPECTIVELY. PATIENTS WHO UNDERWENT BOTH NON-SB AND RA SURGERY HAD THE LONGEST MEDIAN TIME TO FLAIR RESOLUTION (30 MONTHS VS. 4 MONTHS IN SB/RETRACTORLESS, 3.6 MONTHS IN SB/RA, AND 3 MONTHS IN NON-SB/RETRACTORLESS; P < 0.05). POST-OPERATIVE SYMPTOMS OF PATIENTS WHO UNDERWENT ANTERIOR FOSSA MENINGIOMA RESECTION WITH AND WITHOUT SKULL BASE APPROACHES AND RETRACTION -ASSISTED SURGERY: SKULL BASE/RETRACTOR (N=12): ONE (1) NEW MOTOR DEFICIT, ONE (1) SEIZURES, FOUR (4) LENGTH OF HOSPITAL STAY, DAYS. NON-SKULL BASE/RETRACTOR (N=58): SEVEN (7) NEW MOTOR DEFICIT, FIVE (5) NEW LANGUAGE DEFICIT, ONE (1) NEW VISION DEFICIT, FOUR (4) SEIZURES, AND THREE (3) LENGTH OF HOSPITAL STAY, DAYS. CONCLUSION: THE USE OF SB APPROACHES IN COMBINATION WITH RETRACTORLESS SURGERY MAY DECREASE THE DURATION NEEDED FOR FLAIR RESOLUTION AFTER SURGERY. THE RESULTS FROM THIS STUDY THEREFORE ADVOCATE SB APPROACHES AND RETRACTORLESS SURGERY ALONG THE ANTERIOR SB WHEN POSSIBLE.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO COMPLAINT UNIT WILL BE RETURNED AND THUS NO FAILURE ANALYSIS IS POSSIBLE SINCE IT CORRESPONDS TO A STUDY PUBLISHED IN 2018. BASED ON THE ABSENCE OF LOT AND CATALOG INFORMATION OF THE PRODUCTS USED IN THIS RETROSPECTIVE STUDY REVIEW THAT COVERS 136 CASES FROM 2010 TO 2015, IT IS NOT POSSIBLE TO IDENTIFY THE MANUFACTURING TIME FRAME TO BE REVIEWED AND THEREFORE, WAS NOT POSSIBLE TO PERFORM THE DEVICE HISTORY REVIEW. THEREFORE, THE ROOT CAUSE TO THE END USERS EXPERIENCE COULD NOT BE DETERMINED.

Description of Event or Problem

N/A.