BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 5151210 · Received October 15, 2015

    Report

    Report Number
    2028159-2015-08929
    Event Type
    Death
    Date Received
    October 15, 2015
    Date of Event
    June 22, 2015
    Report Date
    January 4, 2016
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINICAL ANALYST HAS REVIEWED THIS FILE AND STATED THE FOLLOWING: ¿THE COMPANY SALES REPRESENTATIVE NOTED THAT HE RECEIVED A CALL FROM THE FACILITY REPORTING A DEATH DURING A RETINAL SURGERY. THE EVENT WAS REPORTED. THE FACILITY RISK MANAGER STATED THAT A PATIENT DIED DURING A VITRECTOMY WITH SCLERAL BUCKLE OF THE RIGHT EYE (OD) INTRAOPERATIVELY. THE SURGEON INDICATED THAT DURING THE VITRECTOMY FLUID AIR EXCHANGE (FAX) THE PATIENT DEVELOPED A CHOROIDAL ELEVATION NASALLY AND TEMPORALLY. THE FACILITY RISK MANAGER STATED THAT NO AUTOPSY WAS DONE. THE FACILITY RISK MANAGER NOTED SHE WOULD BE SUBMITTING A REPORT TO THE FDA. A COPY OF THE FDA VOLUNTARY EVENT REPORT WAS RECEIVED. THE FACILITY NOTED THE ¿PATIENT WAS ADMITTED FOR AN ELECTIVE RIGHT EYE 23 GAUGE VITRECTOMY AND SCLERAL BUCKLE DURING THE END OF VITRECTOMY, PATIENT SUDDENLY DEVELOPED CHOROIDAL ELEVATION BOTH NASALLY AND TEMPORALLY. THE INTRAOCULAR PRESSURE WAS ELEVATED TO ABOUT 60 WHILE THE AIR FLUID EXCHANGE HAD BEEN PERFORMED. AT THE SAME TIME THIS OCCURRED, AN ATTEMPT WAS ABOUT TO BE MADE, TO CUT DOWN ON THE CHOROID TO RELIEVE THE PRESUMED CHOROIDAL HEMORRHAGE, PATIENT SUDDENLY DESATURATE WITH THE OXYGEN LEVEL DROPPING. CODE BLUE WAS INITIATED AND PATIENT WAS INTUBATED. PATIENT SUBSEQUENTLY EXPIRED DESPITE ALL RESUSCITATIVE EFFORTS. ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY RISK MANAGER NOTED THE SYSTEM DID NOT DISPLAY ANY SYSTEM MESSAGES OR POP-UPS; NO THIRD PARTY CONSUMABLES OR ACCESSORIES WERE USED, NOR WERE ANY THIRD PARTY REPAIRED ITEMS USED; NO CHANGES WERE MADE TO THE EXISTING PARAMETERS; THE SETTINGS WERE CONCURRENT WITH THE SURGEON¿S TYPICAL PROCEDURE. THE PATIENT DID NOT HAVE ANY EYE HEALTH HISTORY ISSUES. THE PATIENT DID NOT HAVE ANY RELEVANT HISTORY INCLUDING PRE-EXISTING MEDICAL CONDITIONS (CARDIAC, DIABETES, AUTO-IMMUNE DISORDER, HYPERTENSION, ARTHRITIS, ALLERGIES, ETC.). IN THE SURGEON¿S OPINION THE DEVICE CAUSED/CONTRIBUTED TO THE EVENT. CHOROIDAL DETACHMENT HAS BEEN REPORTED TO BE RELATED TO HYPOTONY AND INTRAOCULAR PRESSURE (IOP) FLUCTUATION. IN A STUDY THAT LOOKED AT RISK FACTORS AND OUTCOMES IN SUPRACHOROIDAL HEMORRHAGE (SCH) DURING PARS PLANA VITRECTOMY (PPV), SIGNIFICANT RISK FACTORS FOR THE DEVELOPMENT OF SCH DURING PPV INCLUDED HIGH MYOPIA HISTORY OF RETINAL DETACHMENT (RD) SURGERY, RHEGMATOGENOUS RETINAL DETACHMENT (RD), USE OF CRYOTHERAPY, SCLERAL BUCKLING AT THE TIME OF PPV, EXTERNAL DRAINAGE OF THE SUB-RETINAL FLUID, AND INTRAOPERATIVE SYSTEMIC HYPERTENSION. OTHER INTRAOPERATIVE FACTORS THAT CAN INFLUENCE THE LIKELIHOOD OF CHOROIDAL HEMORRHAGE LEADING TO DETACHMENT MAY INCLUDE SUDDEN RISE IN BLOOD PRESSURE, A POSITIVE VALSALVA MANEUVER SUCH AS COUGHING, STRAINING, AND SQUEEZING OF THE LIDS BY THE PATIENT, A TIGHT LID SPECULUM CAUSING PRESSURE ON THE GLOBE, OR VITREOUS LOSS DURING SURGERY. UNDER NORMAL CONDITIONS, INTRAOCULAR PRESSURE PUSHES CHOROIDAL BLOOD INTO THE VORTEX VEINS. HOWEVER, WHEN THERE IS A SUDDEN DECREASE IN IOP, THE BLOOD COMING FROM THE ANTERIOR AND POSTERIOR CILIARY ARTERIES CANNOT PASS THROUGH THE VEINS, CAUSING BLOOD TO ACCUMULATE IN THE SUPRACHOROIDAL SPACE. THE PHYSIOLOGIC 1 TO 3 MMHG PRESSURE DIFFERENCE BETWEEN THE SUPRACHOROIDAL AND INTRAOCULAR AREAS USUALLY KEEPS BLOOD FROM ACCUMULATING IN THE SUPRACHOROIDAL SPACE. WHEN THE GLOBE IS OPEN, HOWEVER, THE PRESSURE DIFFERENCE BETWEEN THE TWO AREAS DECREASES SHARPLY. THIS MAY CAUSE THE VESSELS TO RUPTURE, ALLOWING BLOOD TO ESCAPE AND ALLOWING THE CHOROID TO SEPARATE FROM THE SCLERAL WALL. SEVERAL RISK FACTORS SUCH AS ELEVATED INTRAOCULAR PRESSURE (IOP), GLAUCOMA, LOW SCLERA RIGIDITY, HIGH MYOPIA, GENERALIZED ATHEROSCLEROSIS, HYPERTENSION, PERIPHERAL VASCULAR DISEASES, LIVER DISEASE, AGE, AND INCREASED AXIAL LENGTH HAVE BEEN IDENTIFIED AS POTENTIAL CONTRIBUTORS. ALTHOUGH SUPRACHOROIDAL HEMORRHAGES ARE ASSOCIATED WITH HYPOTONY AND INTRAOPERATIVE IOP FLUCTUATIONS, IN THIS CASE, MAJOR CONTRIBUTORS TO THIS EVENT ARE UNKNOWN. AS STATED IN THE SYSTEM OPERATORS MANUAL: ¿THE CLOSED LOOP SYSTEM THAT ADJUSTS IOP CANNOT REPLACE THE STANDARD OF CARE IN JUDGING IOP INTRAOPERATIVELY. THE SURGEON MUST CONTINUE THE COMMON PRACTICE OF INFORMALLY JUDGING THE FOLLOWING: FINGER PALPATION ON THE GLOBE, TACTILE FEEDBACK OF THE SURGICAL INSTRUMENTS, RETINAL VESSEL PERFUSION/PULSATIONS, AND PRESENCE OF CORNEAL EDEMA. IF THE SURGEON BELIEVES THE IOP IS NOT RESPONDING TO THE SYSTEM SETTINGS AND IS DANGEROUSLY HIGH, THE SURGEON CAN DO ONE OR MORE OF THE FOLLOWING AS THEY DEEM APPROPRIATE IN THIS SITUATION (WITH CARE TO AVOID SUDDEN HYPOTONY): CLOSE THE INFUSION STOPCOCK, PINCH THE INFUSION LINE, REMOVE THE INFUSION LINE.¿ FLUID-AIR EXCHANGE (FAX) IS A TECHNIQUE AND STEP IN VITREORETINAL SURGERY AND IS PRIMARILY PERFORMED TO INTRODUCE AN INTRAOCULAR AIR BUBBLE WHICH ASSISTS THE SURGEON IN REATTACHING, FLATTENING AND/OR REPOSITIONING TORN OR DETACHED RETINAL TISSUE. THIS METHOD PROVIDES AIR, HAS A MUCH HIGHER FLOTATION FORCE, AND THEREFORE HAS A MORE TAMPONADE EFFECT ON RETINAL TISSUE THAN BALANCED SALT SOLUTION (BSS). THERE HAVE BEEN PUBLISHED REPORTS CLAIMING THE FORMATION OF AIR EMBOLI WHEN PERFORMING FAX DURING VITREORETINAL SURGERY. AIR EMBOLISM IS PRIMARILY AN IATROGENIC COMPLICATION THAT OCCURS WHENEVER ATMOSPHERIC AIR IS INTRODUCED INTO THE HUMAN SYSTEMIC VASCULAR SYSTEM. IF AIR ENTERS THE CIRCULATORY SYSTEM IN SMALL AMOUNTS OR AT VERY SLOW RATES, IT IS POSSIBLE FOR IT TO BE PHYSIOLOGICALLY ABSORBED INTO THE BLOOD OR REMOVED VIA THE LUNG ALVEOLI WITHOUT CAUSING SIGNIFICANT PROBLEMS. THE MANIFESTATION OF AN AIR EMBOLISM RANGES FROM MINIMAL EFFECTS TO FATAL. THE OCCURRENCE OF AIR EMBOLISM WHEN PERFORMING FAX IN CURRENT AVAILABLE LITERATURE IS NOTED AS RARE.¿ THE SYSTEM WAS EXAMINED. THE COMPANY REPRESENTATIVE DID NOT INDICATE FINDING ANY ISSUES THAT WOULD BE ASSOCIATED WITH THE REPORTED EVENT. THE SYSTEM WAS MANUFACTURED ON MAY 6, 2010. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE SYSTEM WAS FOUND TO MEET SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A RISK MANAGER REPORTED THAT A PATIENT EXPERIENCED A CHOROIDAL ELEVATION NASALLY AND TEMPORALLY DURING THE FLUID AIR EXCHANGE PORTION OF A VITRECTOMY AND SCLERAL BUCKLE SURGICAL PROCEDURE. THE PATIENT EXPIRED ON THE OPERATING ROOM TABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685030 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER TABLETOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death