SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

Report

Report Number: 2210968-2025-03662
Event Type: Death
Date Received: April 7, 2025
Date of Event: July 15, 2024
Report Date: April 10, 2025
Manufacturer: ETHICON INC.
Product Code: LMG
PMA / PMN Number: N12159
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: ET
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: B1, B2, H1 - THIS STUDY WAS DESIGNED TO LOOK INTO THE CAUSES OF ISCHEMIC CEREBROVASCULAR COMPLICATIONS AFTER SKULL BASE TUMOR RESECTIONS. MULTIPLE FACTORS WERE CONSIDERED AS POSSIBLE CONTRIBUTING FACTORS TO THOSE COMPLICATIONS. ALTHOUGH THE USE OF HEMOSTATIC AGENTS WAS MENTIONED IN THE ARTICLE AS ONE STEP FREQUENTLY USED THE STEPS IN CLOSURE OF THE BASE OF THE SKULL, THE USE OF SUCH AGENTS WAS NOT EVALUATED AS ONE OF THE DEPENDENT OR INDEPENDENT VARIABLES IN THE ULTIMATE DEVELOPMENT OF SUCH POSTOPERATIVE COMPLICATIONS. AS SUCH NO RELATIONSHIP BETWEEN THE USE OF SUCH HEMOSTATIC AGENTS AND THE REPORTED COMPLICATIONS CAN BE DRAWN FROM THIS PUBLICATION. THEREFORE, THIS MEDWATCH REPORT IS NOT REPORTABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 0

PRODUCT COMPLAINT # (B)(4). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 1. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER(S). 2. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? 3. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? 4. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. 5. CAN SPECIFIC PATIENT DEMOGRAPHICS: INITIALS; AGE OR DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES OF STUDY DRUGS BE PROVIDED? CITATION: NEUROSURGICAL REVIEW (2024) 47:885 HTTPS://DOI.ORG/10.1007/S10143-024-03132-2. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 0

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SHIFERAW MY, BALEH AS, GIZAW A, TEKLEMARIAM TL, AKLILU AT, AWEDEW AF, ANLEY DT, MEKURIA BH, YESUF EF, YIGZAW MA, MOLLA HT, ADISE MLDIE A, AWANO MM, TEYM A. PREDICTORS OF OPERATIVE ISCHEMIC CEREBROVASCULAR COMPLICATIONS IN SKULL BASE TUMOR RESECTIONS: EXPERIENCE IN LOW-RESOURCE SETTING. NEUROONCOL PRACT. 2024 JUL 15;11(6):790-802. DOI: 10.1093/NOP/NPAE063. PMID: 39554795; PMCID: PMC11567745. THE AIM OF THIS STUDY IS TO IMPROVE RISK STRATIFICATION, SURGICAL DECISION-MAKING, AND POSTOPERATIVE CARE PROTOCOLS. BETWEEN 2018 TO 2023, A MULTI-CENTRIC RETROSPECTIVE COHORT STUDY WAS CONDUCTED ON THE OCCURRENCE AND PREDICTORS OF ISCHEMIC CEREBROVASCULAR COMPLICATIONS AMONG PATIENTS WHO UNDERWENT SKULL BASE TUMOR RESECTION. IN A RETROSPECTIVE COHORT OF SURGICALLY TREATED 266 PATIENTS WITH SKULL BASE TUMORS, THE MEDIAN AGE OF THE PATIENTS WAS 37 (± IQR = 17) YEARS, INDICATING THAT THE AVERAGE AGE OF THE STUDY POPULATION WAS RELATIVELY YOUNG. ADDITIONALLY, THE MAJORITY OF PATIENTS WERE FEMALE, ACCOUNTING FOR 65% OF THE COHORT. THIS GENDER DISTRIBUTION SUGGESTS A POTENTIAL GENDER-BASED DIFFERENCE IN THE INCIDENCE OR PRESENTATION OF SKULL BASE TUMORS. AROUND 15.8% OF PATIENTS HAD COMORBIDITY. THE COMORBIDITIES ASSESSED INCLUDE HYPERTENSION, DIABETES MELLITUS, HIV, BRONCHIAL ASTHMA, CHRONIC KIDNEY, ISCHEMIC CHRONIC DISEASE, CONGESTIVE HEART DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, AND PRIOR ISCHEMIC STROKE. THE SKULL BASE RECONSTRUCTION COMMONLY UTILIZES MULTI-LAYERED TISSUE RECONSTRUCTION, INCLUDING FAT, NASO-SEPTAL FLAP, OSTEO-CARTILAGE TISSUE, AND HEMOSTATIC AGENTS LIKE GEL FOAM &/SURGICEL. REPORTED COMPLICATIONS ARE THE FOLLOWING: BRAIN CONTUSION (N=?) TREATMENT: NOT REPORTED BRAIN SWELLING (N=?) TREATMENT: NOT REPORTED UNKNOWN EVENT (N=?) TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENTS HAD HEMOSTATIC AGENT USE WITH UNKNOWN CAUSE. UNKNOWN EVENT (N=?) TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD DIFFICULT HEMOSTASIS WITH UNKNOWN CAUSE. SUBARACHNOID HEMORRHAGE (SAH) (N=?) TREATMENT: NOT REPORTED. ACUTE SUBDURAL HEMATOMA (ASDH) (N=?) TREATMENT: NOT REPORTED. INTRACEREBRAL HEMORRHAGE (ICH) (N=?) TREATMENT: NOT REPORTED. INTRAVENTRICULAR HEMORRHAGE (IVH) (N=?) TREATMENT: NOT REPORTED. EPIDURAL HEMATOMA (EDH) (N=?) TREATMENT: NOT REPORTED. PNEUMOCEPHALUS (N=?) TREATMENT: NOT REPORTED. MASS EFFECT ON CONTROL CT (N=?) TREATMENT: NOT REPORTED. IATROGENIC INJURY (N=?) TREATMENT: NOT REPORTED. VASOSPASM (N=?) TREATMENT: NOT REPORTED. ISCHEMIC VASCULAR ANTERIOR CEREBRAL ARTERY (ACA) (N=?) TREATMENT: NOT REPORTED. ISCHEMIC VASCULAR BASILAR ARTERY (N=?) TREATMENT: NOT REPORTED. ISCHEMIC VASCULAR MAJOR CORTICAL ARTERY (N=?) TREATMENT: NOT REPORTED. ISCHEMIC VASCULAR ARTERY OF HEUBNER (N=?) TREATMENT: NOT REPORTED. ISCHEMIC VASCULAR INTERNAL CAROTID ARTERY (ICA) (N=?) TREATMENT: NOT REPORTED. ISCHEMIC VASCULAR MIDDLE CEREBRAL ARTERY (MCA) (N=?) TREATMENT: NOT REPORTED. ISCHEMIC VASCULAR MULTIPLE ARTERY TERRITORY (N=?) TREATMENT: NOT REPORTED. ISCHEMIC VASCULAR PERFORATORS (N=?) TREATMENT: NOT REPORTED. CSF LEAK DURING TRANS-SPHENOIDAL SURGERY (N=?) TREATMENT: NOT REPORTED. DEVELOPED MENINGITIS (N=?) TREATMENT: ANTIBIOTICS AND IMPROVED. SUFFERED FROM VASCULAR INSULTS RESULTING TO IN HOSPITAL MORTALITY/DEATH (N=?) TREATMENT: NONE. DIED OF SURGERY RELATED (IATROGENIC) ISCHEMIC STROKE ON THE 4TH POSTOPERATIVE DAY (N=1; 48-YEAR-OLD, FEMALE PATIENT) TREATMENT: NONE. IN CONCLUSION, SURGERY-RELATED ISCHEMIC CEREBROVASCULAR COMPLICATIONS ARE COMMON. THOROUGH PERIOPERATIVE RISK STRATIFICATION AND PROACTIVE TREATMENT PLANNING ARE CRUCIAL TO MITIGATE VASCULAR INSULTS ASSOCIATED WITH IT. IN LOW-RESOURCE SETTINGS, NEUROSURGICAL SERVICES ARE PROVIDED WITHOUT ADVANCED INSTRUMENTS, LEADING TO MORE COMPLICATIONS. THEREFORE, IT IS IMPORTANT TO FOCUS ON IMPROVING NEUROSURGICAL SETUP TO ENHANCE PATIENT OUTCOMES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
571328	SURGICEL ABSORBABLE HEMOSTAT UNKNOWN	AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED	LMG	ETHICON INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Death