MW5039221
Report
- Report Number
- MW5039221
- Event Type
- Death
- Date Received
- November 20, 2014
- Report Date
- November 12, 2014
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
IN SUMMARY, THE EVICEL FIBRIN SEALANT LAPAROSCOPIC APPLICATORS CREATE A SIGNIFICANT SAFETY ISSUE WHEN USED WITH PRESSURIZED GAS BECAUSE THE APPLICATOR SYSTEM OVER PRESSURIZES THE ABDOMINAL CAVITY DURING LAPAROSCOPIC SURGERY. THE FOLLOWING INFORMATION IS BEING SUBMITTED TO FDA REGARDING A SERIOUS SAFETY CONCERN FOR TWO DEVICES MARKETED BY JOHNSON AND JOHNSON (ETHICON INC). THE DEVICES OF ISSUE ARE ACCESSORIES TO THE APPROVED FIBRIN SEALANT PRODUCT EVICEL. SPECIFICALLY, THERE ARE TWO LAPAROSCOPIC APPLICATORS THAT ARE USED WITH EVICEL FIBRIN SEALANT THAT POSE SIGNIFICANT SAFETY RISKS, AND HAVE LIKELY ALREADY BEEN THE DIRECT CAUSE OF SEVERAL REPORTED FATALITIES THAT WERE ASSOCIATED WITH THE USE OF EVICEL FIBRIN SEALANT. IT IS LIKELY THAT THE SPECIFIC CONTRIBUTION OF THESE DEVICES TO THE ADVERSE EVENTS THAT HAVE OCCURRED WERE NOT DETECTED BY FDA BECAUSE OF BOTH LACK OF OVERALL TECHNICAL UNDERSTANDING OF THE FUNCTION OF THESE DEVICES, COMBINED WITH A NON-COMPLIANT 510K REGISTRATION OF THE ACCESSORY DEVICES. THE MODEL NUMBERS OF THE TWO EVICEL LAPAROSCOPIC APPLICATORS ARE #3908 AND #3909. THE ASSOCIATED REGULATOR THAT IS USED WITH THESE APPLICATORS IS MODEL #3905PR. THE FOLLOWING J&J WEBSITE PROVIDES THE PRODUCT ORDER INFORMATION FOR ALL DEVICES FOR EVICEL: HTTP://WWW.ETHICON.COM/HEALTHCARE-PROFESSIONALS/PRODUCTS/BIOSURGERY/EVICEL-FIBRIN-SEALANT-HUMAN. FROM A TECHNICAL PERSPECTIVE, A RAPID RISE IN INTRA-ABDOMINAL PRESSURE (LAP), OVER THE MAXIMUM RECOMMENDED INSUFFLATION PRESSURE OF APPROX 15 MMHG IS WELL ASSOCIATED WITH MANY ADVERSE EVENTS, EVEN AT SHORT DURATIONS OF EXPOSURE SUCH AS APPROX 30 SECONDS (WHICH IS TYPICAL OF A 10 ML FIBRIN SEALANT APPLICATION CYCLE). FURTHER, PEDIATRIC INSUFFLATION PRESSURES ARE RECOMMENDED LOWER THAN 15 MMHG. WHEN ENOUGH GAS IS INSUFFLATED INTRAVENOUSLY (EVEN CO2), IT IS RAPIDLY CARRIED TO THE VENA CAVA AND RIGHT ATRIUM WHERE IT FORMS A GAS LOCK, WHICH IN TURN RESULTS IN OBSTRUCTION TO VENOUS RETURN WITH A PRECIPITOUS FALL IN CARDIAC OUTPUT. VENTRICULAR EXTRA SYSTOLES OR TACHYCARDIA, SINUS BRADYCARDIA, COMPLETE HEART BLOCK OR ASYSTOLE MAY RESULT. CLINICALLY, CARBON DIOXIDE EMBOLISM CAN PRESENT WITH SYSTEMIC HYPOTENSION, DYSPNEA, CYANOSIS,TACHYCARDIA OR BRADYCARDIA, ARRHYTHMIA, OR ASYSTOLE. CARBON DIOXIDE EMBOLISM MAY INCREASE OR DECREASE END-TIDAL CARBON DIOXIDE TENSION. OTHER EFFECTS INCLUDE ELEVATED PULMONARY ARTERIAL PRESSURE (PAP), ELEVATED CENTRAL VENOUS PRESSURE, HYPOXEMIA, AND INCREASED ARTERIAL PARTIAL PRESSURE OF CARBON DIOXIDE. THE MORBIDITY ASSOCIATED WITH THESE EVENTS CAN BE QUITE HIGH ON THE ORDER OF APPROX 30%. ASIDE FROM THE MORBIDITY ASPECTS, EXCESSIVE CO2 ABSORPTION DURING LAPAROSCOPIC SURGERY IS ALSO ASSOCIATED WITH INCREASED SHOULDER PAIN FOLLOWING SURGERY DUE TO CO2 INDUCED NERVE AGITATION. THIS SHOULDER PAIN RESULTS IN LONGER HOSPITAL STAYS, MORE MEDICAL STAFF INTERVENTION, GREATER TIME TO RETURN TO NORMAL FUNCTION, AND THE GREATER USE OF PAIN NARCOTICS. WHILE THE REPORTED NUMBER OF EMBOLISMS WITH THE USE OF SPRAYED EVICEL IS RELATIVELY LOW, WHO KNOWS HOW MANY PATIENTS HAVE HAD INCREASED DEGREE OF SHOULDER PAIN BECAUSE OF THE INCREASED VOLUME OF GAS INTRODUCED DURING SPRAY APPLICATION OF EVICEL IN A LAPAROSCOPIC PROCEDURE. THIS INCREASE IN SHOULDER PAIN WOULD LIKELY NOT BE REPORTED AS AN ADVERSE EVENT UNDER THIS DEVICE BECAUSE THE SURGEON WOULD ASSUME IT WAS RELATED TO CO2 INSUFFLATION ITSELF, AND MAY NOT MAKE THE CONNECTION ABOUT THE EXCESSIVE AMOUNT OF CO2 INTRODUCED BY THE APPLICATOR ITSELF. IT IS NOTED THAT THE J&J INSTRUCTIONS FOR USE WERE RECENTLY CHANGED TO SPECIFY ONLY USE OF CO2 GAS FOR SPRAYING, BUT THIS CHANGE DOES NOT MITIGATE THE POTENTIAL ADVERSE EFFECT IF A SIGNIFICANT VOLUME OF CO2 GAS IS INJECTED INTO THE ENCLOSED SPACE OF THE ABDOMEN. AND, THE INSUFFLATORS USED TO ESTABLISH THE PERITONEUM ARE NOT DESIGNED TO VENT GAS. THE INSUFFLATORS ONLY INJECT GAS TO ACHIEVE THE DESIRED SETPOINT PRESSURE, AND WITH THE NATURAL TROCAR PORT LEAKAGE DURING THE COURSE OF THE SURGERY, THE INSUFFLATOR WILL CONTINUE INJECTING SMALL VOLUMES OF GAS TO MAINTAIN THAT SETPOINT. THE AVERAGE ADULT ONLY REQUIRES 2.5 LITERS OF GAS TO DISTEND THE PERITONEUM ADEQUATELY,WHICH RESULTS IN AN INTRA-ABDOMINAL PRESSURE OF 8-10 MMHG. THE GAS FLOWRATES OF THE EVICEL LAPAROSCOPIC APPLICATORS ARE ON THE AVERAGE OF 6 SLPM. WITH THIS SIGNIFICANT VOLUME OF GAS BEING INTRODUCED INTO THE PERITONEUM, WITHOUT ANY GAS VENTING, THE LAP WILL ALWAYS RAPIDLY RISE. IN FACT, EVEN AN (B)(4) SPONSORED STUDY PUBLISHED IN 2007, BY K. T. ORUCKREY-FISKAAEN ET AL, TITLED "LAPAROSCOPIC SPRAY APPLICATION OF FIBRIN SEALANT EFFECTS ON HEMODYNAMICS AND SPRAY EFFICIENCY AT VARIOUS APPLICATION PRESSURES AND DISTANCES" CLEARLY SHOWS THE PROBLEMS CREATED WITH THE EVICEL LAPAROSCOPIC DEVICE. (B)(4) TRIED TO SOFTEN THE CONCLUSION TO INDICATE THAT THE DEVICE COULD POTENTIALLY BE MADE SAFE IF THE SURGEON OPENS THE TROCAR VENT VALVE WHILE SPRAYING AND USES ONLY VERY SHORT DURATIONS OF SPRAY SUCH AS 5 SECONDS. BUT EVEN WITH THE TROCAR VALVE OPEN, THE LAP PRESSURE STILL RISES ABOVE 20 MMHG WHICH IS NOT A SAFE LEVEL AS DESCRIBED BY MANY PUBLICATIONS, AND WITH THE TROCAR VALVE CLOSED, IT GOES EVEN HIGHER TO COMPLETELY UNSAFE LEVELS. IT IS NOTED THAT THERE IS NO MENTION OF OPENING ANY TROCAR VALVE OR LIMITING THE DURATION OF SPRAY TIME IN THE IFU FOR EVICEL DURING LAPAROSCOPIC SPRAYING. FURTHER, OPENING A TROCAR VALVE DURING SURGERY WILL RESULT IN THE PERITONEUM TO COLLAPSE, AND THEN THE INSUFFLATOR WILL PUMP MORE GAS TO TRY AND RESTORE THE SETPOINT. THEN WITH THE SIMULTANEOUS COMBINATION OF SPRAYING GAS AT 6 SLPM WITH THE INSUFFLATION GAS REPLACEMENT VOLUME,THIS WILL RESULT IN A VERY SIGNIFICANT RISE IN LAP. IT IS EXTREMELY DISTURBING THAT AFTER THIS STUDY WAS CONDUCTED, (B)(4) DID NOTHING FURTHER TO MITIGATE THIS SIGNIFICANT SAFETY ISSUE. SEVERAL OTHER COMPANIES THAT MANUFACTURE LAPAROSCOPIC BIOMATERIAL APPLICATORS THAT INVOLVE GAS-ASSISTED SPRAYING HAVE PROPERLY IDENTIFIED THESE SAFETY ISSUES, AND THEY HAVE DESIGNED DEVICES THAT PROPERLY MANAGE THE EXTRA VOLUME OF GAS THAT IS INTRODUCED INTO THE BODY DURING SPRAYING. BAXTER'S TISSEEL FIBRIN SEALANT HAS A GAS-ASSISTED LAPAROSCOPIC APPLICATOR CALLED DUPLOSPRAY (510K K061092). DUPLOSPRAY SPRAYS TISSEEL FIBRIN SEALANT AT A GAS FLOW RATE OF APPROXIMATELY 2-3 STANDARD LITERS/MINUTE. BUT THE GAS REGULATOR THAT PROVIDES THE PRESSURIZED GAS WORKS IN CONJUNCTION WITH THE APPLICATOR TUBING SET WHICH IS ATTACHED TO THE VENT VALVE ON THE TROCAR. WHEN SPRAYING IS INITIATED, A VENT VALVE IS OPENED ON THE GAS REGULATOR THAT ALLOWS GAS TO BE REMOVED FROM THE BODY THROUGH THE TROCAR VENT VALVE AND APPLICATOR TUBING SET. THE SYSTEM IS ESSENTIALLY 100% EFFICIENT WHERE THE VOLUME OF GAS INTRODUCED IS VENTED OUT AT THE SAME VOLUME. THIS RESULTS IN NO INCREASE IN THE VOLUME OF GAS IN THE ABDOMEN, AND THUS PREVENTS ANY RISE IN THE INTRA-ABDOMINAL PRESSURE. FURTHER, BECAUSE OF THE REGULATORY FILING STATUS OF THE EVICEL LAPAROSCOPIC APPLICATORS, THE LITERAL EXISTENCE OF THESE DEVICES HAS BEEN MASKED BY THE MISLEADING 510K SUBMISSION FROM THE ORIGINAL CROSSEAL DEVICE SUBMISSION. AS YOU CAN REVIEW FOR YOURSELF, THERE WAS NEVER ANY MENTION OF THE SPECIFIC LAPAROSCOPIC DEVICES IN ANY OF THE SLOK SUBMISSIONS FOR THE EVICEL APPLICATORS, SO FDA NEVER HAD THE APPROPRIATE OPPORTUNITY TO CLOSELY REVIEW THE SAFETY OF THOSE SPECIFIC DEVICES. I CAN ONLY ASSUME THAT IF THESE DEVICES WERE SPECIFICALLY REVIEWED BY FDA, THE SAFETY OF THESE EXISTING DEVICES WOULD NEVER PASS THE SCRUTINY OF A SPECIFIC 510K REVIEW. AS ONE EXAMPLE, IF YOU REVIEW THE FDA GUIDANCE DOCUMENT ON 510KS AND WHEN TO FILE, SPECIFICALLY IN THE SITUATION WHERE THE PROPOSED INDICATION IS DIFFERENT THAN THE ORIGINAL DEVICE, A NEW 510K MUST BE FILED (SEE HTTP://WWW.FDA.GOV/MEDICALDEVICES/DEVICEREGULATIONANDGUIDANCE/GUIDANCEDOCUMENTS/UCM080235). FURTHER, IF YOU REVIEW THIS GUIDANCE DOCUMENT, THEN YOU CAN CLEARLY SEE THAT THE FDA EXAMPLE DESCRIBES THIS SITUATION EXACTLY. DOES THE CHANGE AFFECT THE INDICATIONS FOR USE? AS WITH AN EXPLICIT LABELING CHANGE, IF THE CHANGE AFFECTS THE INDICATIONS FOR USE, I.E., IF IT CREATES AN IMPLIED NEW INDICATION FOR USE, A NEW 510(K) SHOULD BE SUBMITTED. AN EXAMPLE OF THIS WOULD BE CHANGING THE LENGTH OF A SURGICAL SCISSOR FROM 10 CENTIMETERS TO 30 CENTIMETERS SO THAT THE DEVICE COULD BE USED IN LAPAROSCOPIC PROCEDURES. THE ORIGINAL INDICATION FOR USE WAS FOR OPEN SURGICAL PROCEDURES, WHILE THE NEW INDICATION FOR USE WOULD BE FOR CLOSED, ENDOSCOPICALLY-CONTROLLED PROCEDURES. NOTE THAT EVEN THOUGH A SURGICAL SCISSOR IS EXEMPT FROM THE REQUIREMENT TO SUBMIT A 510(K) BY REGULATION, ONE MUST STILL EVALUATE THE CHANGE TO ASSURE THAT THE CHANGE DOES NOT AFFECT THE DEVICE'S CLASSIFICATION OR EXEMPTION STATUS. IT IS ONLY A MATTER OF TIME BEFORE ANOTHER FATALITY WILL OCCUR WITH THESE DEVICES ON THE MARKET. APPROXIMATELY (B)(4) OF ALL EVICEL SOLD IN THE US MARKET IS USED WITH THESE DEVICES (2012 IMS DATA SOURCE). J&J HAS BEEN EXTREMELY IRRESPONSIBLE WITH THE MANAGEMENT OF THIS ISSUE. WITH THE STUDY THEY EVEN CONDUCTED THEMSELVES (VIA THEIR SUBSIDIARY (B)(4)), THEY MUST BE WELL AWARE OF THE POTENTIAL RISKS THEY ARE IMPOSING ON PATIENTS YET THEY HAVE DONE NOTHING. FURTHER, EVEN THEIR COMPETITORS SUCH AS BAXTER IS WELL AWARE OF THIS RISK AND ONLY PROVIDES A GAS-ASSISTED LAPAROSCOPIC APPLICATOR FOR THEIR FIBRIN SEALANT THAT VENTS THE ADDITIONAL GAS INTRODUCED DURING LAPAROSCOPIC GAS-ASSISTED SPRAYING OF A BIOMATERIAL. I HOPE THIS ISSUE IS INVESTIGATED THOROUGHLY BY FDA AND RAPID AND APPROPRIATE MEASURES ARE TAKEN TO PROTECT THE PUBLIC. IN MY OPINION, THESE DEVICES SHOULD BE IMMEDIATELY RECALLED FROM THE MARKET UNTIL J&J CAN MAKE THE APPROPRIATE DESIGN CHANGES TO MITIGATE THESE SAFETY ISSUES, AND RESUBMIT THEM THROUGH THE PROPER REGULATORY PROCESS FOR 510K REGULATED DEVICES.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | EVICEL |