ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A MIDLINE STERNOTOMY FOLLOWED BY AN AORTIC ARCH REPLACEMENT PROCEDURE ON (B)(6) 2012 AND SUTURE WAS USED TO CLOSE THE BREAST BONE WITH KNOTTED SUTURING TECHNIQUE. THE SURGEON USED 3 OR 4 KNOTS WITH EACH STITCH. ON (B)(6) 2012, THE PATIENT UNDERWENT CT SCAN, AND IT WAS FOUND THAT WOUND DEHISCED AT THE BREAST BONE AND EXUDATE FLUID WAS OBSERVED. ON (B)(6) 2012, THE PATIENT UNDERWENT A RE-OPERATION. AT THAT TIME, THE SURGEON OPENED THE PATIENT'S BREAST AND REMOVED THE BROKEN AND INTACT PARTS OF THE SUTURE. THE KNOTS REMAINED INTACT, BUT THE SUTURE BODY WAS BROKEN. THE SURGEON ALSO NOTED A NEW STERNA FRACTURE. THE SUTURES HAD SEVERED THE STERNUM. THE SURGEON CLOSED THE BREAST BONE USING STEEL AND THE RE-OPERATION WAS COMPLETED. THE PATIENT IS STILL HOSPITALIZED AND IS DOING WELL. THE SURGEON OPINES THE CAUSE FOR THE SUTURE BREAKAGE WAS THE SUTURING TECHNIQUE AND THE PATIENT'S 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. ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBER: BATCH DJE028. THIS IS ONE OF SIX MEDWATCHES BEING SUBMITTED AS SIX DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-00361, MEDWATCH 2210968-2012-00362, MEDWATCH 2210968-2012-00363, MEDWATCH 2210968-2012-00365, AND MEDWATCH 2210968-2012-00366. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

Additional Manufacturer Narrative

CONCLUSION: A RETURNED EXPLANTED KNOTTED GREEN BRAIDED SUTURE WAS MICROSCOPICALLY EXAMINED. THE SUTURE HAD TWO BROKEN ENDS AND SIGNIFICANT ABRASION DAMAGE WAS PRESENT ON THE SUTURE. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBER: BATCH DJE028, MFG DATE: 08/01/2011; EXP DATE: 07/31/2016. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.