FLOSEAL HEMOSTATIC MATRIX
Report
- Report Number
- 2954761-2011-00050
- Event Type
- Death
- Date Received
- September 2, 2011
- Date of Event
- August 17, 2011
- Report Date
- September 2, 2011
- Manufacturer
- BAXTER HEALTHCARE - HAYWARD
- Product Code
- LMF
- PMA / PMN Number
- P990009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
(B)(4). BAXTER HAS DISCUSSED THE CONCLUSION OF THE CLINICAL INVESTIGATION WITH THE REPORTING SURGEON AND HE AGREES WITH THE RESULTS.
(B)(4). BAXTER FOLLOW-UP MEDICAL ASSESSMENT: THE CONCLUSION OF THIS CLINICAL INVESTIGATION ARE AS FOLLOWS: THE FOREIGN MATERIAL PRESENT IN THE CLOT HAS BEEN IDENTIFIED AS FLOSEAL GELATIN GRANULES. GIVEN THE USE OF FLOSEAL IN THE PRESENCE OF ACTIVE BLEEDING AND THE LONG-TIME APPLICATION EXPERTISE OF THE OPERATING NEUROSURGEON WE CAN EXCLUDE AN INCORRECT APPLICATION OF THE PRODUCT INTO THE VASCULAR SYSTEM (PRIMARY INTRAVASCULAR APPLICATION EXCLUDED). THE APPLICATION OF 10 ML OF FLOSEAL INTRAVASCULARLY WOULD HAVE DETERMINED AN IMMEDIATE SEVERE LUNG EMBOLISM WITH CARDIAC ARREST, WHICH WAS NOT THE CASE. THE DELAYED OCCURRENCE OF THE THROMBOEMBOLIC SYMPTOMS POINTS TO A LATER MIGRATION OF CLOT FRAGMENTS CONTAINING FLOSEAL INTO THE VENOUS VASCULAR SYSTEM, WITH GRADUAL BUILD-UP OF AN EMBOLUS OVER SEVERAL HOURS. IT APPEARS THAT A MAJOR CONTRIBUTOR TO THE EVENT WAS THE POSITIONING OF THE PATIENT IN A MODIFIED KNEE-ELBOW POSITION. THE GENU-PECTORAL POSITIONING IN A CONSIDERABLY OBESE PATIENT (B)(6) MAY CAUSE A NEGATIVE PERIPHERAL VENOUS PRESSURE IN THE APPLICATION AREA (PRESACRAL VEIN PLEXUS) OF FLOSEAL AS COMPARED TO THE VENOUS PRESSURE IN THE RIGHT ATRIUM APPLICATION SITE HIGHER THAN RIGHT ATRIUM). THIS MAY FAVOR A"SUCTION" EFFECT IN THE VEIN AND EXPLAINS THE DELAYED DEVELOPMENT OF THE FATAL SYMPTOMS. THE MIGRATION OF A THROMBUS MAY HAVE OCCURRED LATER DURING SURGERY, WHEN THE PATIENT EXPERIENCED A TEMPORARY DROP IN BLOOD PRESSURE. THE INITIAL SIZE OF THIS MIGRATED THROMBUS HAS NOT BEEN SUFFICIENT TO OCCLUDE THE PULMONARY ARTERY, AND THIS EXPLAINS THE OCCURRENCE OF FIRST CLINICAL SYMPTOMS OF THE SEVERE PULMONARY EMBOLISM ABOUT 10 HOURS AFTER SURGERY. THE SERIOUS ADVERSE EVENT HAS BEEN TRIGGERED BY THE INDICATED, CORRECT USE OF FLOSEAL BUT WAS MAINLY CAUSED BY PATIENT, AND SURGERY RELATED FACTORS (OBESITY AND SACRUM ABOVE RIGHT HEART LEVEL). THE RESULTS AND CONCLUSIONS OF THIS EXTENSIVE INVESTIGATION SHOULD BE SHARED AND COMMUNICATED TO THE REPORTER. BAXTER MANUFACTURING INVESTIGATION: A REVIEW OF THE NONCONFORMANCE/EXCEPTIONS DATABASE INDICATES THAT LOT NUMBER HA101209 WAS MANUFACTURED WITHOUT ANY NONCONFORMANCE/EXCEPTION. TWELVE (12) RETAINED SAMPLES FOR LOT NUMBER HA101209 WERE VISUALLY INSPECTED FOR ABNORMALITIES. NO ABNORMALITIES WERE OBSERVED. ONE (1) RETAIN SAMPLE WAS RECONSTITUTED PER THE IFU TO DETERMINE IF THE PRODUCT WAS WITHIN SPECIFICATION. NO ABNORMALITIES WERE OBSERVED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON REVIEW OF INVESTIGATION WITH THE REPORTER.
(B)(4): BAXTER MEDICAL ASSESSMENT: APPARENTLY THE PATHOLOGIST HAS DEMONSTRATED FLOSEAL MATERIAL IN THE POSTMORTEM EXAMINATION OF THE THROMBOEMBOLIC MATERIAL IN A CASE OF FATAL LUNG EMBOLISM. ALTHOUGH BASED ON THE LIMITED CLINICAL AND SURGICAL APPLICATION INFORMATION THE CIRCUMSTANCES AND FAVORING FACTORS OF THE INCIDENT CANNOT BE CLARIFIED, A CAUSAL RELATIONSHIP WITH THE USE OF FLOSEAL CANNOT BE DENIED. A USER ERROR OR ALTERNATIVE PATHOLOGY- AND/OR SURGERY-ASSOCIATED FACTORS HAVE TO BE INVESTIGATED. FOLLOWING QUESTIONS HAVE TO BE CLARIFIED (B)(4): INDICATION FOR SURGERY AND INTRAOPERATIVE COURSE, INDICATION FOR USING FLOSEAL AND APPLICATION CIRCUMSTANCES (PRESENCE OF ACTIVE BLEEDING, VOLUME OF PRODUCT APPLIED, APPLICATION DEVICE USED, WAS THE BLEEDING SOURCE VISIBLE, SIZE OF LESION, ETC.), HAS COPIOUS COMPRESSION BEEN USED?, WAS THE PATIENT POSITIONED IN A SEMI-SITTING (SURGICAL FIELD HIGHER THAN RIGHT ATRIUM) POSITION? PATENT FORAMEN OVALIS?, WHERE THERE OTHER REASONS FOR A LOW OR NEGATIVE PERIPHERAL VENOUS PRESSURE?, HAS A BLOOD SALVAGE SYSTEM (E.G. CELL SAVER) BEEN USED DURING THE FLOSEAL APPLICATION?, WHEN, IN RELATION TO THE APPLICATION OF FLOSEAL DID THE THROMBOEMBOLIC EVENT OCCUR (SECONDS, MINUTES OR HOURS AFTER APPLICATION)?, (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.
ADDITIONAL INFORMATION RECEIVED BY BAXTER (B)(4): ON (B)(6) 2011 FROM 11:05 AM TO 5:00 PM, THE PATIENT UNDERWENT SURGERY ON A PARAVERTEBRAL SPACE OCCUPYING PROCESS ON THE LEFT SIDE IN THE L5/S1 AREA WITH SUSPECTED NEURINOMA. DUE TO PRESACRAL VENOUS HEMORRHAGE, FLOSEAL 2X 5 ML WAS USED FOR HEMOSTASIS. HEMOSTASIS WAS SUCCESSFUL WITHOUT RELEVANT BLOOD LOSS AND IT WAS POSSIBLE TO CONTINUE THE INTERVENTION. DURING THE SURGERY, AFTER THE HEMORRHAGE HAD BEEN DEALT WITH, THERE WAS A BRIEF DROP IN BLOOD PRESSURE THAT IMPROVED AGAIN QUICKLY. REPEATED HB CHECKS DID NOT SHOW ANY SERIOUS DROP, THEREFORE THE SURGERY COULD BE COMPLETED WITH FULL TUMOR RESECTION. AFTER SURGERY, THE PATIENT WAS EXTUBATED AND WAS MONITORED IN THE RECOVERY WARD WITHOUT ANY PROBLEMS AND THEN TRANSFERRED TO THE NORMAL WARD. AROUND 10:00 PM, DURING A POST-OP VISIT, THE PATIENT SUDDENLY COMPLAINED OF MALAISE, DYSPNEA WITH VOMITING AND A BRIEF SYNCOPE. OVER THE FURTHER COURSE, A CT SCAN OF THE THORAX (BILATERAL UPPER AND MIDDLE LOBES) DISCLOSED A FULMINANT PULMONARY EMBOLISM. THERE WAS DECOMPENSATED RIGHT HEART FAILURE. THE PATIENT DIED ON (B)(6) 2011 AT 12:10 PM OF HEART FAILURE. THERE WAS A FULMINANT PULMONARY EMBOLISM IN THE PATHOLOGICAL AUTOPSY. THE HISTOLOGICAL ANALYSIS OF THE PULMONARY EMBOLISM SHOWED PARTS OF TRAPPED GELATIN PARTICLES IN LARGE SECTIONS, WHICH INDICATED SUSPECTED MIGRATION OF FLOSEAL. A MICROSCOPIC EXAMINATION OF FLOSEAL PERFORMED INDEPENDENTLY FROM THIS SITUATION DISCLOSED THE SAME PARTICLE FORMATIONS. MEDICAL CONSEQUENCES OR SYMPTOMS: THE DIAGNOSIS AT ADMISSION WAS A PARAVERTEBRAL SPACE OCCUPYING PROCESS IN THE LEFT L5/S1 AREA WITH SUSPECTED NEURINOMA. THERE WERE ALSO OTHER CONSIDERABLE INTERNAL PREVIOUS CONDITIONS: MORBID OBESITY, COPD, SYSTEMIC HYPERTENSION. SURGERY OF THE PARASPINAL TUMOR WAS STARTED ON (B)(6) 2011 AT 11:05 AM. THE SURGERY TOOK PLACE IN MODIFIED KNEE-ELBOW POSITION. AFTER DEPICTION OF THE LEFT PARASPINAL L5/S1 AREA, THERE WAS A BRIEF PRESACRAL HEMORRHAGE, WHICH WAS ABLE TO BE CONTROLLED IMMEDIATELY USING FLOSEAL. THE SURGERY WAS THEN CONTINUED TO FULL TUMOR RESECTION AND COMPLETED. AFTER THE SURGERY ON (B)(6) 2011 AROUND 10:00 PM DURING A VISIT, THE PATIENT COMPLAINED OF DYSPNEA AND MALAISE AFTER TURNING IN BED. THERE WAS A BRIEF SYNCOPE, WHICH STABILIZED QUICKLY. THE CT OF THE THORAX SHOWED MARKED FULMINANT PULMONARY EMBOLISMS ON BOTH SIDES. THIS WAS CLINICALLY ASSOCIATED WITH MASSIVE DECOMPENSATED RIGHT HEART FAILURE. REPEATED CARDIOVERSION HAD TO BE PERFORMED. HOWEVER, IT WAS NOT POSSIBLE TO STABILIZE THE PATIENT. THE PATIENT DIED ON (B)(6) 2011 AT 12:10 PM OF HEART FAILURE. THE AUTOPSY INDICATED THAT THE CAUSE OF DEATH WAS A FULMINANT PULMONARY EMBOLISM WITH RIGHT HEART FAILURE. THERE WAS EMBOLIZATION OF FLOSEAL FROM THE PRESACRAL REGION AFTER USING THE PRODUCT IN THIS AREA.
AFTER APPLICATION OF FLOSEAL DURING A SURGERY (DETAILS UNKNOWN) THE PATIENT (FEMALE) DEVELOPED PULMONARY EMBOLISM AND DIED. ACCORDING TO THE HISTOLOGICAL EXAMINATION THE EMBOLISM WAS CAUSED BY FLOSEAL. THIS IS AN EXPERIENCED CUSTOMER AND USED FLOSEAL IN THE PAST WITHOUT ANY DIFFICULTIES. ADDITIONAL INFORMATION RECEIVED ON (B)(6)-2011: DATE OF SURGERY: (B)(6) -2011
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLOSEAL HEMOSTATIC MATRIX | AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED | LMF | BAXTER HEALTHCARE - HAYWARD | HA101209 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Death |