UNKNOWN CERTAS PLUS VALVE
Report
- Report Number
- 3013886523-2022-00495
- Event Type
- Malfunction
- Date Received
- November 1, 2022
- Report Date
- April 27, 2023
- Manufacturer
- INTEGRA LIFESCIENCES SWITZERLAND SAR
- Product Code
- JXG
- PMA / PMN Number
- NI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
THE CERTAS VALVE WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED; HOWEVER, THE MOST PROBABLE ROOT CAUSE IS MOST LIKELY ATTRIBUTABLE TO THE UNDERLYING HEALTH CONDITIONS OF THE PATIENTS WITHIN THE STUDY. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.
THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00497. THIS REPORT IS FOR ADVERSE EVENTS TO INCLUDE: OBSTRUCTION/OCCLUSION. NMC CASE REPORT JOURNAL 8, 573¿577, (2021) PUBLISHED, " ACUTE OCCLUSION OF THE VENTRICULOPERITONEAL SHUNT DUE TO FACTOR XIII DEFICIENCY-RELATED POSTOPERATIVE HEMORRHAGE: A CASE REPORT". ABSTRACT: "COAGULATION FACTOR XIII (F13) DEFICIENCY HAS BEEN KNOWN TO BE A RARE DISEASE WITH ESTIMATED ONE PER TWO MILLION AND ONE OF THE POSSIBLE REASONS OF POSTOPERATIVE HEMORRHAGE; HOWEVER, IT STILL REMAINS UNPENETRATED TO PHYSICIANS. WE REPORT A CASE OF ACUTE VENTRICULOPERITONEAL (VP) SHUNT DYSFUNCTION DUE TO DELAYED INTRAVENTRICULAR HEMORRHAGE, WHICH COULD BE BECAUSE OF F13 DEFICIENCY. THE PATIENT WAS A 48-YEAR-OLD MAN WITH A HISTORY OF POST-MENINGITIS HYDROCEPHALUS FOLLOWED BY VP SHUNT PLACEMENT. HE WAS FOUND UNCONSCIOUS AND TRANSFERRED TO OUR HOSPITAL. A BRAIN CT SCAN DEMONSTRATED SHUNT MALFUNCTION, AND HE UNDERWENT EMERGENCY SHUNT REVISION. THE POSTOPERATIVE COURSE WAS UNEVENTFUL EXCEPT FOR UNEXPECTED NECK BRUISES AND CONTINUOUS MINOR BLEEDING FROM THE SURGICAL WOUND. THREE DAYS AFTER SURGERY, HE SUDDENLY BECAME COMATOSE AND A CT SCAN REVEALED THE RECURRENCE OF HYDROCEPHALUS WITH NEWLY IDENTIFIED SMALL VOLUME OF INTRAVENTRICULAR HEMORRHAGE. EMERGENCY SHUNT REVISION WAS PERFORMED AGAIN. THE SHUNT VALVE WAS FILLED WITH A HEMATOMA AND BLOODY CEREBROSPINAL FLUID WAS DRAINED FROM THE VENTRICLE. POSTOPERATIVE BLOOD SAMPLE EXAMINATION DEMONSTRATED NO ABNORMAL FINDINGS BUT A DECREASED LEVEL OF F13 ACTIVITY, WHICH WAS THOUGHT TO BE A POSSIBLE CAUSE OF POSTOPERATIVE HEMORRHAGE AND THE SHUNT VALVE HEMATOMA. F13 DEFICIENCY CAUSES DELAYED INTRACRANIAL HEMORRHAGE 24¿48 H AFTER NEUROLOGICAL SURGERY. IT CAN ONLY BE DIAGNOSED BY CHECKING F13 ACTIVITY WITH SUSPICION. IF DIAGNOSED ACCURATELY BEFOREHAND, UNEXPECTED POSTOPERATIVE BLEEDING CAN BE PREVENTABLE WITH PROPER TREATMENT, SUCH AS F13 CONCENTRATE AND CRYOPRECIPITATE. THE ACTUAL NUMBER OF THE PATIENT WITH F13 DEFICIENCY MAY BE MORE THAN ESTIMATED EVER." CASE REPORT :THE PATIENT WAS A 48-YEAR-OLD MAN WHO WAS PERFORMED A RIGHT VENTRICULOPERITONEAL (VP) SHUNT FOR POST-MENINGITIS HYDROCEPHALUS AT 7 MONTHS OF AGE. TWO MONTHS AFTER THE OPERATION, BILATERAL SUBDURAL HEMATOMAS WERE FOUND AND REMOVED BY BILATERAL CRANIOTOMIES. MULTIPLE VP SHUNT RECONSTRUCTIONS WERE SUBSEQUENTLY PERFORMED. THE LAST SHUNT RECONSTRUCTION SURGERY WAS PERFORMED WHEN HE WAS 11 YEARS OLD. HE HAD INTELLECTUAL DISABILITIES AND HIS INTELLECT WAS AROUND 12 YEARS OLD. HE HAD RESIDUAL LEFT HEMIPLEGIA AND WAS REGULARLY TAKEN TO THE OUTPATIENT CLINIC WITH A 4-POINT CANE. THERE WAS NO OTHER MEDICAL HISTORY OR FAMILY HISTORY TO BE NOTED. HE VISITED OUR HOSPITAL DUE TO A DAY-LONG DISTURBANCE OF CONSCIOUSNESS. HE WAS COMATOUS AND A BRAIN CT SCAN SHOWED PROGRESSIVE VENTRICULAR ENLARGEMENT AND DISAPPEARANCE OF THE SULCUS WHICH SUGGESTED SHUNT MALFUNCTION. CHEST ABDOMINAL CT SHOWED THAT THE ABDOMINAL TUBE HAD COME OUT OF THE ABDOMINAL CAVITY. SHUNT RECONSTRUCTION WAS PERFORMED URGENTLY ON THE SAME DAY. FIRST OPERATIVE FINDINGS: THE SHUNT VALVE WAS A DIFFERENTIAL PRESSURE TYPE. SINCE THE VENTRICULAR CATHETER TIGHTLY ADHERED TO SURROUNDINGS, ITS REMOVAL WAS ABANDONED. A NEW VENTRICULAR TUBE WAS INSERTED FROM THE BRAIN SURFACE AFTER VENTRICULAR PUNCTURE. CLEAR, NON-BLOODY CEREBROSPINAL FLUID (CSF) WAS DRAINED FROM THE CATHETER. CODMAN CERTAS PLUS (INTEGRA LIFESCIENCES, PRINCETON, NJ, USA) WAS USED AS THE VALVE AND THE OPERATION WAS COMPLETED IN A STANDARD MANNER WITHOUT ANY DIFFICULTY OF HEMOSTASIS. THE AMOUNT OF BLEEDING WAS TOO SMALL TO MEASURE. POSTOPERATIVE COURSE: ON THE NEXT DAY, HE REGAINED CONSCIOUSNESS AND HAD NO NEW NEUROLOGICAL DEFICIT OTHER THAN THE ORIGINAL LEFT HEMIPLEGIA. POSTOPERATIVE COURSE WAS UNEVENTFUL EXCEPT FOR CONTINUOUS MINOR BLEEDINGS FROM THE HEAD AND ABDOMINAL WOUNDS. SUBCUTANEOUS HEMORRHAGIC BRUISES WERE ALSO OBSERVED ALONG THE SHUNT PATHWAY IN THE RIGHT NECK AND CHEST. BRAIN CT ON POSTOPERATIVE DAY 1 SHOWED A DECREASED VENTRICULAR SIZE AND A TINY VOLUME OF VENTRICULAR HEMATOMA THAT FORMED A SLIGHT NIVEAU IN THE VENTRICLES. ON POSTOPERATIVE DAY 3, HE SUDDENLY EXPERIENCED BRADYCARDIA, APNEA, AND LOSS OF CONSCIOUSNESS. THE SHUNT VALVE WAS IMMEDIATELY PUNCTURED, AND A PRESSURE MEASUREMENT WAS TAKEN; THE INTRACRANIAL PRESSURE WAS OVER 40 CM H2O. THE BLOODY CSF WAS THEN QUICKLY DRAINED. IMMEDIATELY AFTER THIS MANEUVER, HIS RESPIRATORY STATUS, HEART RATE, AND CONSCIOUSNESS LEVEL IMPROVED SLIGHTLY. THE SUBSEQUENT CT SCAN DEMONSTRATED PROGRESSED VENTRICULOMEGALY WITH INTRAVENTRICULAR HEMORRHAGE AND SUBCUTANEOUS HEMATOMA AROUND THE SHUNT VALVE. THE PARENCHYMAL PERICATHETER HEMORRHAGE WAS ALSO NOTICED (FIG. 1C); CONSEQUENTLY, EMERGENCY SHUNT RECONSTRUCTION WAS PERFORMED. ON THE BLOOD TEST, THE PLATELET COUNT WAS 165000/L, ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) WAS 30.8 S, PROTHROMBIN TIME-INTERNATIONAL NORMALIZED RATIO (PT-INR) WAS 1.08, AND FIBRINOGEN WAS 454 MG/DL. SECOND OPERATIVE FINDINGS: THE PROGRAMMABLE PORTION OF THE VALVE WAS FILLED WITH A HEMATOMA (FIG. 3), WHICH WAS CONSIDERED TO CAUSE THE ACUTE SHUNT OCCLUSION, WHILE THERE WAS NO HEMATOMA IN RESERVOIR PORTION OF THE VALVE, WHICH WAS FILLED WITH SLIGHTLY BLOODY CSF. OUTFLOW OF CSF FROM THE VENTRICULAR CATHETER WAS GOOD, WHILE THE INTRAVENTRICULAR CSF WAS BLOODY, AND THE PRESSURE WAS 50 CMH2O. SINCE THE PRESENCE OF THE BLOODY CSF MAY HAVE BLOCKED THE SHUNT AGAIN, CSF WAS WASHED REPEATEDLY WITH ARTCEREB (B)(4) JAPAN) (1 L WAS USED) USING A NEWLY INSERTED VENTRICULAR CATHETER TILL IT BECAME ALMOST COLORLESS. THE PERITONEAL CATHETER WAS PATENT AND CODMAN HAKIM PROGRAMMABLE VALVE (INTEGRA LIFESCIENCES) WAS PLACED. AFTER THE SECOND SURGERY, HIS CONSCIOUSNESS GRADUALLY IMPROVED. HEMORRHAGE FROM THE WOUND WAS ALSO NOTED AT THIS TIME BUT COULD BE MANAGED CONSERVATIVELY. THE PATIENT WAS REFERRED TO THE HEMATOLOGY DEPARTMENT FOR FURTHER INVESTIGATION OF THIS HEMOR¬RHAGIC EVENT, WHICH REVEALED THAT F13 ACTIVITY HAD DECREASED TO 49% (NORMAL VALUE: 70%¿140%) ON POSTOPERATIVE DAY 3 BY QUANTITATIVE ASSAY (AMMONIA RELEASE ASSAY). THERE WAS A RECOVERY TO 60% ON THE 12TH DAY AND 84% ON THE 31ST DAY; THEREFORE, THE PATIENT WAS DIAGNOSED WITH F13 DEFICIENCY. F13 INHIBITOR AND AUTOANTIBODY WERE NOT EVALUATED. COAGULATION FACTOR V, VIII, AND VON WILLEBRAND FACTOR WERE NOT EVALUATED, WHILE OTHER COAGULATION-RELATED FACTORS SUCH AS APTT, PT-INR, PROTEIN C ACTIVITY, PROTEIN S ACTIVITY, ANTITHROMBIN III, AND LUPUS ANTICOAGULANT WERE ALL IN NORMAL RANGE. SINCE THEN, HE HAS HAD GOOD PROGRESS AND HAS RECOVERED. HE WAS DISCHARGED ON THE 23RD DAY AFTER SURGERY. DISCUSSION: "TO THE BEST OF OUR KNOWLEDGE, THIS IS THE FIRST REPORT THAT F13 DEFICIENCY CAUSED ACUTE VP SHUNT MALFUNCTION DUE TO A VALVE HEMATOMA FROM DELAYED INTRAVENTRICULAR HEMORRHAGE. F13 DEFICIENCY IS KNOWN TO BE A VERY RARE DISEASE AND COULD BE A PLAUSIBLE CAUSE OF POSTOPERATIVE HEMORRHAGE; HOWEVER, IT HAS A LOW CLINICAL PENETRANCE AND IS UNFAMILIAR TO MANY CLINICIANS." DOI: 10.2176/NMCCRJ.CR.2020-0330.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 639733 | UNKNOWN CERTAS PLUS VALVE | CERTAS PLUS | JXG | INTEGRA LIFESCIENCES SWITZERLAND SAR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |