FLOSEAL HEMOSTATIC MATRIX

Report

Report Number: 2954761-2008-00057
Event Type: Injury
Date Received: November 18, 2008
Date of Event: April 9, 2008
Report Date: November 17, 2008
Manufacturer: BAXTER HEALTHCARE - HAYWARD
Product Code: LMF
PMA / PMN Number: P990009
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

BAXTER MEDICAL ASSESSMENT: THIS IS ONE OF SEVEN REPORTS FROM RECENT PEER-REVIEWED PUBLICATION [HEMKEL, A., COOPER, R.A., WARD, K.A., BOVA, D., & YAO, K. (2008). MALIGNANT-APPEARING MICROCALCIFICATIONS AT THE LUMPECTOMY SITE WITH THE USE OF FLOSEAL HEMOSTATIC SEALANT. AJR AM J ROENTGENOL, 191 (5), 1371-1873]. THE PUBLICATION DESCRIBES BENIGN MAMMOGRAPHIC CALCIFICATIONS THAT OCCUR AT THE LUMPECTOMY SITE AFTER USE OF FLOSEAL. SINCE THESE CALCIFICATIONS MAY HAVE AN APPEARANCE SIMILAR TO THAT OF RECURRENT CARCINOMA, THEY MAY MASK A RECURRENT TUMOR GROWTH AND THUS NEGATIVELY IMPACT THE TIMELY THERAPEUTIC MANAGEMENT OF THESE MALIGNANCIES. ACCORDING TO THE OPERATING SURGEON (FOLLOW-UP) 5ML FLOSEAL HAVE BEEN APPLIED IN ALL SEVEN CASES AFTER HEMOSTASIS HAS BEEN ACHIEVED. ALL SEVEN REPORTED CASES SHOW A SERIES OF THREE USER ERRORS, WHICH ARE IN CONFLICT WITH THE FLOSEAL INSTRUCTIONS FOR USE: FLOSEAL APPLICATION (5ML) IN THE ABSENCE OF ACTIVE BLEEDING. THE EXCESS PRODUCT (MATERIAL NO INCORPORATED IN THE HEMOSTATIC CLOT), WHICH IN THE ABSENCE OF BLEEDING HAS BEEN ABOUT 5 ML OF NON-REACTED FLOSEAL, HAS NOT BEEN IRRIGATED AND LEFT IN SITU. APPLICATION OF FLOSEAL AGAINST THE IFU WARNING THAT FLOSEAL MATRIX"...IS NOT INTENDED TO BE USED AS A PROPHYLACTIC HEMOSTATIC AGENT." THIS FALSE EXPECTATION IS ALSO ENFORCED IN THE "MATERIAL AND METHODS" SECTION OF THE PUBLICATION IN WHICH FLOSEAL IS WRONGLY PRESENTED AS AN ALTERNATIVE TO FIBRIN SEALANTS (WHICH INDEED HAVE THE ABILITY TO PREVENT POSTOPERATIVE BLEEDING, BASED ON THEIR SEALING PROPERTIES). IN THE AREA OF THE BREAST, TISSUE TENDS TO CALCIFY. THIS APPLIES TO RECURRENT BREAST TUMORS, BUT ALSO TO FOREIGN BODIES LEFT IN PLACE. WITH A HIGH DEGREE OF CERTAINTY THE DESCRIBED CLINICAL SITUATION OUTLINED IN THE PUBLICATION OF HENKEL ET AL. IS SUGGESTIVE FOR CALCIFICATIONS OF THE RESIDUAL FLOSEAL GELATIN GRANULES, WHICH ARE VISIBLE IN THE RADIOLOGIC FOLLOW-UP. THE SIX CASES (MARKED PATIENT #1 - #6) WHICH SHOWED MULTIPLE MICROCALCIFICATIONS AFTER SIX MONTHS MIGHT BE SEEN AS NON SERIOUS INJURIES, SINCE THE PATIENTS DID NOT EXPERIENCE ANY RELATIVE SYMPTOMS. NEVERTHELESS, THE PRESENCE OF EVEN ASYMPTOMATIC CALCIFICATIONS IS POTENTIALLY NEGATIVELY IMPACTING PATIENT SAFETY, SINCE AT FOLLOW-UP MAMMOGRAPHIC EXAMINATION, THESE CALCIFICATIONS MAY MASK MALIGNANT MICROCALCIFICATIONS THAT OFTEN REPRESENT AN INDICATOR OF CANCER RECURRENCE. THE DELAYED DIAGNOSIS MAY NEGATIVELY IMPACT TIMELY SURGERY, AND THE ENTIRE OUTCOME OF TREATMENT. ALSO, AS A POTENTIALLY ADDED RISK SITUATION IS THE REPORT OF THE ONE PATIENT (PATIENT #7) WHO HAS BEEN RE-OPERATED AFTER ONE MONTH UNDER THE ASSUMPTION THAT THE MICROCALCIFICATIONS MAY BE MALIGNANT (WHICH HAS BEEN INFORMED BY HISTOLOGY). THIS SITUATION MAY EXPOSE THE PATIENT TO ADDITIONAL RISKS OF A SECOND, NEEDLESS SURGERY AND GENERAL ANESTHESIA. WHAT EVER OF THESE TWO SITUATIONS OCCURS, THIS MAY POTENTIALLY HAVE A NEGATIVE IMPACT ON SECONDARY PATIENT SAFETY. MAMMOGRAPHY IS AN ESSENTIAL PART OF THE FOLLOW-UP PROGRAM IN ORDER TO DETECT A RECURRENCE IN THE TREATED BREAST AS WELL AS A CANCER IN THE CONTRALATERAL BREAST CANCER. THE OPTIMAL INTERVAL FOR FOLLOW-UP MAMMOGRAPHY HAS NOT BEEN DETERMINED, ALTHOUGH PROGRAMS EMPLOYING MAMMOGRAPHY ON A YEARLY BASIS AFTER TREATMENT HAVE BEEN ASSOCIATED WITH THE DETECTION OF EARLY RECURRENCES AND EXCELLENT SURVIVAL AFTER SALVAGE MASTECTOMY FOR THESE RECURRENCES. IN CONCLUSION: FLOSEAL APPLIED AT THE LUMPECTOMY SITE MIMICS THE APPEARANCE OF MALIGNANT MICROCALCIFICATIONS, THUS LIMITING EVALUATION FOR RESIDUAL OR RECURRENT DISEASE, OR FALSELY SUGGESTING THE NEED FOR SURGICAL RE-INTERVENTION. ALL THE ASPECTS OF THE ABOVE DESCRIBED USER ERRORS ARE CLEARLY AND REPEATEDLY ADDRESSED IN THE FLOSEAL IFU. THE REPORTING SURGEON HAS BEEN RE-/TRAINED AN ALL THE ABOVE ASPECTS OF CORRECT PRODUCT APPLICATION DURING THE FOLLOW UP DISCUSSION (BAXTER, MEDQ BIOSURGERY). IF FLOSEAL IS INDICATED AND APPLIED AS OUTLINED IN THE INSTRUCTIONS FOR USE THIS PRODUCT CAN - AGAINST THE RECOMMENDATION IN THE PUBLICATION - BE SAFELY USED FOR HEMOSTASIS ON BREAST TISSUE. AS THE REPORTING SURGEON HAS BEEN ADVISED OF THE CORRECT PRODUCT APPLICATION AND AS THE ARTICLE WRITTEN IS ADDRESSING THE IMPROPER USE OF THE PRODUCT, NO FURTHER ACTIVITY IS REQUIRED.

Description of Event or Problem · 1

PATIENT #7. FROM LITERATURE: BOVA, D., COOPER, R.A., HENKEL, A., WARD, K., AND YAO, K. (2008). MALIGNANT-APPEARING MICROCALCIFICATIONS AT THE LUMPECTOMY SITE WITH THE USE OF FLOSEAL HEMOSTATIC SEALANT. AMERICAN ROENTGEN RAY SOCIETY, AJR 2008; 191:W1371-W1373. SUMMARY OF PUBLICATION FROM AJR WOMEN'S IMAGING (COMPLETE ARTICLE ATTACHED): RECENTLY AT MEDICAL CENTER, FLOSEAL WAS USED FOR HEMOSTASIS DURING SEVEN LUMPECTOMIES PERFORMED FOR TREATMENT OF BREAST CANCER. FOLLOW-UP MAMMOGRAMS FOR ALL SEVEN PATIENTS IN WHOM FLOSEAL WAS USED SHOWED INNUMERABLE PUNCTUATE RADIOPAQUE DENSITIES THROUGHOUT THE LUMPECTOMY SITE THAT MIMICKED THE APPEARANCE OF MALIGNANT MICROCALCIFICATIONS. IN THE SEVENTH PATIENT, THE MICROCALCIFICATIONS WERE OBSERVED ON A MAMMOGRAM OBTAINED 1 MONTH AFTER LUMPECTOMY BEFORE RADIATION THERAPY TO EVALUATE FOR RESIDUAL MALIGNANT CALCIFICATIONS. THIS FINDING CONTRIBUTED TO THE DECISION TO PERFORM REEXCISION LUMPECTOMY IN THS SEVENTH PATIENT, AND PATHOLOGY RESULTS REVEALED NUMEROUS BENIGN MICROCALCIFICATIONS. THE RISK FOR RECURRENT DISEASE AFTER TREATMENT OF BREAST CANCER IF HIGHEST IN THE FIRST 5 YEARS AFTER SURGERY. FLOSEAL WAS APPLIED TO AN EXCISED BREAST SPECIMEN, BUT SAW NO MICROCALCIFIC DENSITIES WHEN THE SPECIMEN UNDERWENT BOTH ANALOG AND DIGITAL EXAMINATION. THEREFORE, THE DEVELOPEMENT OF CALCIFICATIONS IS A RESPONSE TO FLOSEAL THAT REQUIRES A LIVING HOST. THE GELATIN MATRIX AND THROMBIN-BASED HEMOSTATIC AGENT FLOSEAL APPLIED AT A LUMPECTOMY SITE MIMICS THE APPEARANCE OF MALIGNANT MICROCALCIFICATIONS ON MAMMOGRAPHY, THUS LIMITING EVALUATION FOR RESIDUAL OR RECURRENT DISEASE AND IS NOT RECOMMENDED FOR USE ON BREAST TISSUE. ADDITIONAL INFORMATION RECEIVED ON 10-NOV-08: DR, THE OPERATING SURGEON IN THE SEVEN FLOSEAL CASES STATED THAT AFTER COMPLETING THE LUMPECTOMY, SHE OBTAINED HEMOSTASIS USING CAUTERY. SHE THEN COATED THE RESECTION BED WITH FLOSEAL, CLOSED THE INCISION AND APPLIED A COMPRESSION BRA AAS PART OF THE ROUTINE WOUND DRESSING. NO IRRIGATION WAS USED. PERFORMING A ONE MONTH POST OPERATIVE MAMMOGRAM WAS NOT THEIR ROUTINE, HOWEVER, THE ONE PATIENT (PATIENT # 7) REQUIRED THIS PRIOR TO INITIATING RADIATION THERAPY. IT WAS THIS PATIENT WHO DEMONSTRATED THE MOST MICROCALCIFICATIONS. THE OTHER SIX PATIENTS WHO RECEIVED FLOSEAL IN THIS MANNER HAD ROUTINE SIX MONTH POST OPERATIVE MAMMOGRAMS, AND SHOWED LESS IMPRESSIVE MICROCALCIFICATIONS, BUT ONES THAT WERE CLEARLY QUESTIONED IF THEY WERE RECURRENCES OF THE TUMOR OR FLOSEAL. DR AND THE RADIOLOGY TEAM LOOKED AT THE CONTENTS OF FLOSEAL AND SAW IT DID CONTAIN CALCIUM CHLORIDE, WHICH THEY THOUGHT CONTRIBUTED TO THE MICROCALCIFICATIONS. GIVEN THE IMPORTANCE OF MAMMOGRAPHY IN BREAST CANCER THERAPY, SHE FELT THIS WAS A REMARKABLE FINDING AND WANTED TO INFORM HER COLLEAGUES VIA THE PUBLICATION. THE INDICATION FOR USE OF FLOSEAL AND THE REQUIREMENT TO APPLY THE PRODUCT ONLY ONTO SITES THAT WERE VISIBLY BLEEDING WAS EXPLAINED TO DR. MATRIX THAT IS INCORPORATED IN THE HEMOSTATIC CLOT IS LEFT IN SITU, WHILE ALL EXCESS MATRIX IS REMOVED WITH GENTLE IRRIGATION. THE FLOSEAL CLOT IS BROKEN DOWN AND RESORBED WITHIN 6 - 8 WEEKS, WHEN EXCESS MATERIAL IS REMOVED. WITHOUT THE REMOVAL OF EXCESS MATRIX, THE EXCESS MATERIAL IS NOT BROKEN DOWN DURING THE FIBRINOLYSIS OF THE HEMOSTATIC CLOT. THE BREAKDOWN AND RESORPTION OF LOOSE MATRIX HAS NOT BEEN STUDIED. DR STATED THAT SHE THOUGHT SHE COULD USE FLOSEAL TO PREVENT HEMATOMA FORMATION IF THE PATIENT WAS TO BLEED POST-OPERATIVELY, BUT NOW CLEARLY UNDERSTANDS THAT IT HAS NO PLACE AS A PROPHYLACTIC AGENT. REP ALSO INDICATED THAT DR HAS LEFT THIS USER FACILITY AND CANNOT OBTAIN THE PATIENT'S CHART DATA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FLOSEAL HEMOSTATIC MATRIX		LMF	BAXTER HEALTHCARE - HAYWARD	N/A	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other