FDA Adverse Event Injury Summary report: N

SURGIFLO W. THROMBIN

MDR report key: 12525123 · Received September 24, 2021

Report

Report Number
3008478369-2021-00018
Event Type
Injury
Date Received
September 24, 2021
Manufacturer
FERROSAN MEDICAL DEVICES A/S
Product Code
LMF
PMA / PMN Number
P990004
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

LITERATURE (ARTICLE). CSF RHINORRHOEA AFTER ENDONASAL INTERVENTION TO THE SKULL BASE (CRANIAL) - PART 1: MULTICENTER PILOT STUDY, KHAN DZ ET AL. WORLD NEUROSURGERY (2021) 149:E1077-E1089. HTTPS://DOI.ORG/10.1016/J.WNEU.2020.12.171. A PROSPECTIVE OBSERVATIONAL COHORT STUDY WAS PILOTED AT 12 TERTIARY NEUROSURGICAL UNITS IN THE UNITED KINGDOM. FEEDBACK REGARDING PROJECT POSITIVES AND CHALLENGES WERE QUALITATIVELY ANALYZED. DATA WERE COLLECTED ON 187 PATIENTS ACROSS THE TERTIARY NEUROSURGICAL CENTERS, BETWEEN NOVEMBER 2019 AND JULY 2020. THE MEDIAN AGE OF PATIENTS WITHIN THE STUDY WAS 52 YEARS. MOST TUMORS WERE PITUITARY ADENOMAS (N =142/187, 76%), MOSTLY MACROADENOMAS (N = 132/142, 93%). THERE WERE 96 NONFUNCTIONING PITUITARY ADENOMAS (N = 96/142, 68%), OF WHICH 95 WERE MACROADENOMAS (N = 95/96, 99%). OF THE FUNCTIONING PITUITARY ADENOMAS (N = 46/142, 32%), 30 WERE MACROADENOMAS (N = 30/46, 65%).IN TSA CASES, THE MOST COMMONLY USED METHOD FOR INTRAOPERATIVE SKULL BASE REPAIR WAS TISSUE GLUE EVICEL (ETHICON, NEW JERSEY, USA), GRAFTS WERE USED IN 77 CASES. THE MOST COMMON DONOR SITE FOR THE TISSUE GRAFT WAS THE ABDOMEN. A SPONGOSTAN (ETHICON, NEW JERSEY, USA) SYNTHETIC GRAFT WAS USED IN 40 CASES. SEVERAL HEMOSTATIC AGENTS WERE USED, SUCH AS SURGIFLO (ETHICON, NEW JERSEY, USA), SURGICEL (ETHICON,NEW JERSEY, USA), FIBRILAR (ETHICON, NEW JERSEY,USA). IN TERMS OF EEA CASES, THE MOST COMMONLY USED METHOD FOR INTRAOPERATIVE SKULL BASE REPAIR WAS TISSUE GLUE EVICEL (ETHICON),A SPONGOSTAN SYNTHETIC GRAFT WAS USED. SEVERAL HEMOSTATIC AGENTS WERE USED SUCH AS SURGICEL, SURGIFLO(ETHICON). REPORTED COMPLICATIONS INCLUDED :IN TSA SYNDROME OF INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION (N=4), MENINGITIS (N=1), SELLAR ABSCESS(N=1), MONO-OCULAR BLINDNESS(N=1). IN EEA SYNDROME OF INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION (N=1), MENINGITIS (N=1). CASE 2: (B)(6) YEARS OLD MALE WITH POSTOPERATIVE CSF RHINORRHEA. CASE 4: (B)(6) YEARS OLD MALE WITH POSTOPERATIVE CSF RHINORRHEA. CASE 5: (B)(6) YEARS OLD FEMALE WITH POSTOPERATIVE CSF RHINORRHEA. CASE 8 (B)(6) YEARS OLD FEMALE WITH POSTOPERATIVE CSF RHINORRHEA. IN CONCLUSION PILOT EXPERIENCE HIGHLIGHTS THE ACCEPTABILITY AND FEASIBILITY OF CRANIAL. THERE IS A PRECEDENT FOR MULTICENTER DISSEMINATION OF THIS PROJECT, TO ESTABLISH A BENCHMARK OF CONTEMPORARY PRACTICE IN SKULL BASE NEUROSURGERY, PARTICULARLY WITH RESPECT TO PATIENTS UNDERGOING EEA. PATIENT 1 OF 2, QN (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1424596 SURGIFLO W. THROMBIN LMF FERROSAN MEDICAL DEVICES A/S

Patients

Seq Age Sex Outcome Treatment
1