CONNECTOR 45103 CSF-CATH STRAIGHT IMP

Description of Event or Problem

LIN, Z., LIAO, D., ZHENG, D., LIN, F., LIN, Y., JIANG, Z., REN, X., LIN, S. COMPARISON OF TEMPORAL-TO-FRONTAL HORN SHUNT AND VENTRIC ULO-PERITONEAL SHUNT FOR TREATMENT OF TRAPPED TEMPORAL HORN: A RETROSPECTIVE COHORT STUDY. NEUROSURGICAL REVIEW. 2023. 46 (77-87) HTTPS://DOI.ORG/10.1007/SL0143-023-01981-X AS A LOCALIZED HYDROCEPHALUS, TRAPPED TEMPORAL HORN (TTH) CAN BE EFFECTIVELY RESOLVED VIA CEREBROSPINAL FLUID SHUNTING. IN ADDITION TO CONVENTIONAL VENTRICULO-PERITONEAL SHUNT (VPS), TEMPORAL-TO-FRONTAL HORN SHUNT (TFHS) HAS BEEN DESCRIBED AS A LESS COMPLEX AND INVASIVE PROCEDURE WITH PROMISING RESULTS; HOWEVER, THERE IS LIMITED DATA COMPARING VPS TO TFHS REGARD­ING PATIENT OUTCOMES. THIS STUDY AIMS TO COMPARE TFHS VERSUS VPS FOR TREATMENT OF TTH. WE CONDUCTED A COMPARATIVE COHORT STUDY WITH PATIENTS UNDERGOING TFHS OR VPS FOR TTH AFTER SURGERY OF TRIGONAL OR PERITRIGONAL TUMORS BETWEEN 2012 AND 2021. THE PRIMARY OUTCOME WAS REVISION RATES AT 30-DAY, 6-MONTH, AND I-YEAR. SECONDARY OUTCOMES INCLUDED OPERATIVE DURATION, POSTOPERATIVE PAIN, HOSPITAL STAY, OVERDRAINAGE, AND COST FOR SHUNT PLACEMENT AND REVISION. A TOTAL OF 24 PATIENTS INCLUDED, WITH 13 (54.2%) PATIENTS RECEIVING TFHS AND 11 (45.8%) RECEIVING VPS. BOTH COHORTS SHARED SIMILAR BASELINE CHARACTERISTICS. THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN TFHS AND VPS IN 30-DAY (7 .7% VS 9.1 %, P > 0.99), 6-MONTH (7.7% VS 18.2%, P=0.576), OR I-YEAR (8.3% VS 18.2%, P=0.590) REVISION RATES. THERE WERE NO SIGNIFICANT DIFFERENCES IN TERMS OF OPERATIVE DURATION (93.5 ±24.1 VS 90.5 ±29.6 MIN, P=0.744), SURGICAL SITE PAIN (0 VS 18.2%, P=0.199), OR POSTOPERATIVE LENGTH OF STAY (4.8±2.6 VS 6.9 ±4.0 DAYS, P=0.157) BETWEEN THE TWO GROUPS. FOR THE TFHS COHORT, NO PATIENT EXPERIENCED SHUNT RELATED OVERDRAINAGE, AND THERE WAS A TREND TOWARDS FEWER OVERDRAINAGE (0% VS 27 .3%, P = 0.082) COMPARED WITH VPS. TFHS OFFERED SIGNIFICANT REDUCTION IN COST FOR INITIAL SHUNT (¥20,417 VS ¥33,314, P=0.030) AND TOTAL COSTS FOR SHUNT AND REVI­SION (¥21,602 VS ¥43,196, P = 0.006) COMPARED TO VPS. AS A TECHNIQUE OF VALVELESS SHUNT AND WITHOUT ABDOMINAL INCISION, TFHS IS COSMETIC, COST-EFFECTIVE, AND COMPLETELY FREE OF OVERDRAINAGE WITH SIMILAR REVISION RATES AS COMPARED WITH VPS. REPORTABLE EVENTS: 3 PATIENTS (12.5%, 3/24) EXPERIENCED SHUNT FAILURE AND REQUIRED REVISION SURGERY 1 PATIENT (4.2%, 1/24) REQUIRING MULTIPLE REVISIONS MOST COMMON INDICATION FOR SHUNT REVISION WAS PROXI­MAL OBSTRUCTION (66.7%, 4/6). DISTAL OBSTRUCTION (16.7%, 1/6), ASCITES AND ILEUS (16.7%, 1/6), AND SHUNT INFECTION (16.7%, 1/6) 5 CATHETER REVISIONS (83.3%, 5/6) AND 1 SHUNT REMOVAL (16. 7%, 1/6) A 23 YEAR OLD FEMALE READ­MITTED TO OUR INSTITUTION WITH PROGRESSIVE HEADACHE ADDITIONAL INFORMATION RECEIVED INDICATED THAT MEDTRONIC DEVICES WERE NOT THE CAUSES OF THE EVENTS.

Additional Manufacturer Narrative

H3) NO DEVICES HAVE BEEN RETURNED FOR ANALYSIS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.