ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACIC AORTA AND AORTIC ARCH TOTAL REPLACEMENT ON (B)(6) 2012 AND SUTURE WAS USED. ON (B)(6) 2012, THE PATIENT EXPERIENCED WOUND DEHISCENCE AT THE BREAST BONES. THE PATIENT WAS RE-OPERATED ON AT THAT TIME. DURING THE OPERATION THE SURGEON NOTED THAT ALL OF THE SUTURES WERE BROKEN. THE SUTURES WERE REMOVED AND THE PATIENT WAS RECLOSED WITH WIRES AND BANDS. THE REOPERATION WAS SUCCESSFUL AND THE PATIENT IS STABLE IN THE ICU. THE SURGEON OPINES THAT THE SUTURES MAY HAVE BEEN SCRATCHED BY THE EDGES OF THE BONE AND PUT UNDER PRESSURE BY THE PATIENT COUGHING.

Additional Manufacturer Narrative

(B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBER: BATCH DCB312. THIS IS ONE OF EIGHT MEDWATCHES BEING SUBMITTED AS EIGHT DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCHES 2210968-2012-04200, 2210968-2012-04201, 2210968-2012-04202, 2210968-2012-04203, 2210968-2012-04205, 2210968-2012-04206, 2210968-2012-04207, 2210968-2012-04208. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

Additional Manufacturer Narrative

(B)(4): THE ACTUAL SUTURE WAS RETURNED AND MICROSCOPICALLY EVALUATED. THE SUTURE WAS KNOTTED AND HAD BROKEN ENDS WITH EVIDENCE OF ABRASION DAMAGE. THE AMOUNT OF FORCE REQUIRED TO CAUSE THE BREAKAGE COULD NOT BE DETERMINED. THE BREAKAGE MAY HAVE BEEN RELATED TO ABRASION DAMAGE. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBER WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.