ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A MITRAL VALVE REPAIR PROCEDURE ON (B)(6) 2011 AND SUTURE WAS USED. AFTER THE HEART WAS CLOSED, THE SURGEON PERFORMED A SCAN OF THE HEART AND NOTICED ENDS OF THE SUTURE WERE FLAPPING. THE SURGEON REOPENED THE HEART AND ON ALL SEVEN KNOTS ON THE SUTURE STRAND WERE UNTIED. THE SURGEON REPAIRED THE VALVE A DIFFERENT WAY AND IT IS UNKNOWN WHAT SUTURE WAS USED TO COMPLETE THE REPAIR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

Additional Manufacturer Narrative

(B)(4). KNOTS UNTYING. 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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2011-00601, 2210968-2011-00602, AND 2210968-2011-00603. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

Additional Manufacturer Narrative

(B)(4). THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE FOLLOWING ARE POSSIBLE BATCH NUMBERS: (B)(4), MFG DATE: 08/01/2009, EXP DATE: 07/31/2014. (B)(4), MFG DATE: 08/01/2008, EXP DATE: 07/31/2013. 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. RESULT: REPRESENTATIVE SAMPLES OF THE PRODUCTS WERE TESTED FOR KNOT PULL TENSILE STRENGTH AND THE RESULTS OBTAINED WERE IN CONFORMANCE WITH THE REQUIREMENTS. CONCLUSION. NO DEVICE FAILURE DETECTED AND THE PRODUCTS ARE WITHIN SPECIFICATION.