Description of Event or Problem · 1
IT WAS REPORTED TO THE COMPANY BY A HEALTHCARE PROFESSIONAL THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY SURGERY USING TISSUGLU SURGICAL ADHESIVE IN CONJUNCTION WITH STANDARD OF CARE ON (B)(6) 2016. ON (B)(6) 2017, THE PATIENT'S SURGEON CONDUCTED AN ADDITIONAL SURGICAL PROCEDURE TO CLEAN AND CLOSE AN ABDOMINAL POCKET CONTAINING FLUID. IT WAS REPORTED THAT DURING THIS PROCEDURE PIECES OF UNCURED TISSUGLU® SURGICAL ADHESIVE WERE FOUND IN POTENTIALLY INFECTED ENCAPSULATED SEROMA TISSUE. DR (B)(6) SURGICALLY REMOVED AND CLEANED THE WOUND AND PLACED A DRAIN. THE DRAIN WAS SUBSEQUENTLY REMOVED AND NO FURTHER ISSUES REPORTED. IT WAS FURTHER REPORTED THAT ON (B)(6), THE PATIENT PRESENTED WITH FLUID DEVELOPMENT IN A DIFFERENT AREA OF THE ABDOMEN. THE DOCTOR REPORTEDLY ASPIRATED THE FLUID FROM THIS AREA TWO SEPARATE TIMES WITHOUT RESOLUTION AND DECIDED TO PERFORM AN ADDITIONAL REVISION SURGICAL PROCEDURE. THE HEALTHCARE PROFESSIONAL RESPONSIBLE FOR THE PATIENT'S CARE ALLEGES THE COMPLICATIONS TO BE ASSOCIATED WITH THE USE OF TISSGLU SURGICAL ADHESIVE. THE REPORTED FLUID DEVELOPMENT AND PRESENCE OF TISSUGLU® SURGICAL ADHESIVE FRAGMENTS IS CONSISTENT WITH KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH ABDOMINOPLASTY SURGERIES AND IS DESCRIBED IN THE TISSUGLU SURGICAL ADHESIVE DIRECTIONS FOR USE (DFU-100-0001): · POTENTIAL ADVERSE EVENTS (E.G., COMPLICATIONS) RELATED TO ABDOMINOPLASTY PROCEDURES IN GENERAL INCLUDE SEROMA FORMATION, WOUND DEHISCENCE, RASH/ REDNESS, SURGICAL SITE INFECTION, NECROSIS, HYPERTROPHIC SCARRING, HEMATOMA, WOUND COMPLICATIONS, WOUND SEPARATION, AND IMMUNOLOGICAL REACTION. TISSUGLU® SURGICAL ADHESIVE HAS BEEN SHOWN CLINICALLY TO NOT INCREASE OR EFFECT THE RATE OF THESE COMPLICATIONS IN ABDOMINOPLASTY PROCEDURES. · AS DESCRIBED IN THE DIRECTIONS FOR USE, TISSUGLU IS DESIGNED TO PROVIDE A STRONG BOND FOR A PERIOD OF TIME SUFFICIENT FOR NATURAL HEALING TO OCCUR AND EVENTUALLY DEGRADES OVER TIME, BREAKING DOWN INTO BENIGN ABSORBABLE COMPONENTS. IN A 24 MONTH PRECLINICAL STUDY, THE TEST ARTICLE DEGRADED MOST SIGNIFICANTLY OVER THE FIRST 6 MONTHS, AFTER WHICH THE FORMATION OF A FIBROTIC CAPSULE AROUND THE RESIDUAL TEST ARTICLE APPARENTLY SLOWED THE DEGRADATION PROGRESSION OVER THE REMAINING DURATION OF THE 24 MONTH IMPLANTATION PERIOD. IT IS NOT ANTICIPATED THAT THE EXISTENCE OF TISSUGLU® WILL PRESENT ANY ADVERSE REACTION, INFECTION, OR OTHER HEALTH CONSEQUENCES. THE INVOLVED LOT OF TISSUGLU® WAS CONFIRMED TO BE WITHIN FINAL RELEASE ACCEPTANCE CRITERIA. BASED ON THE ABOVE, COHERA MEDICAL CONCLUDES THAT NO FURTHER ACTION IS NEEDED AT THIS TIME.