CHORDX LOOP

Additional Manufacturer Narrative

THE FOLLOWING WAS ASKED TO THE REP ON 12/01/2016 IN A LAST ATTEMPT TO UNDERSTAND THE REPORTED EVENT, "WE WILL NEED TO KNOW WHETHER THE PAPILLARY SUTURE PULLED OUT OF THE PAPILLARY OR WHETHER IT REMAINED (IN PART) ANCHORED TO THE PAPILLARY WHEN FAILURE OCCURRED. THE ORIGINAL COMPLAINT IS STATED AS, 'UPON TYING THE 3RD SUTURE ON THE LEAFLET, THEN ENTIRE SUTURE BROKE AND PULLED OUT OF THE PAPILLARY MUSCLE. HE REMOVED THE REMAINING SUTURE AND FREE PLEDGET', WHICH DOES NOT ALLOW FOR A CLEAR CONCLUSION.¿ THE REP RESPONDED THE SAME DAY, ¿NO INSIGHT," THE SURGEON "COULD NOT CONCLUDE EXACTLY WHERE THE FAILURE OCCURRED." THE MANUFACTURING RECORDS FOR THE CXL-30-1838-24, LOT Z156013500, WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. ALL LOTS PASSED FUNCTIONAL TESTING AND MET RELEASE SPECIFICATIONS. THE FOLLOWING POTENTIAL FAILURE MODES ARE IDENTIFIED: PAPILLARY MUSCLE SUTURE BREAKS POST IMPLANTATION (PLEDGETS LOOSE). PAPILLARY MUSCLE SUTURE UNRAVELS POST IMPLANTATION (PLEDGETS LOOSE). POSSIBLE CAUSES FOR THIS FAILURE ARE IDENTIFIED BELOW AND ARE LISTED IN THE DFMEA: EPTFE SUTURE NOT TO STRENGTH SPECIFICATION. SUTURE MATERIAL NOT STRONG ENOUGH FOR APPLICATION. SUTURE DEGENERATES AND BREAKS DUE TO NICK OR CUT. SUTURE MATERIAL DEGRADES IN BODY. SUTURE LOOP KNOT BUNDLES REDUCE SUTURE STRENGTH. KNOT INTEGRITY REDUCED DUE TO FRAYING INDUCED THROUGH USE OF SHARP TOOLS (SUCH AS KNOT-PUSHER). THE LANGUAGE OF THE COMPLAINT AS WELL AS FOLLOW-UP INFORMATION, DO NOT ALLOW A CLEAR CONCLUSION REGARDING A DEFINITIVE FAILURE MODE IN THIS CASE. AS STATED IN THE INITIAL COMPLAINT, 'AS HE [SURGEON] WAS TYING THE 2ND SUTURE ON THE LEAFLET, HE FELT A SLIPPAGE OF THE SUTURE. UPON TYING THE 3RD SUTURE ON THE LEAFLET, THE ENTIRE SUTURE BROKE AND PULLED OUT OF THE PAPILLARY MUSCLE. HE REMOVED THE REMAINING SUTURE AND FREE PLEDGET.' THIS INITIAL STATEMENT POINTS TO TWO DIFFERENT FAILURE MODES: THE PAPILLARY SUTURE SURGEON-TIED KNOTS UNRAVELED AND THE ENTIRE SUTURE ASSEMBLY PULLED OUT OF THE PAPILLARY, FREEING THE PLEDGET ATTACHED NEAR THE SURGEON-TIED KNOTS AND THE PAPILLARY SUTURE BROKE AT THE INTERSECTION WITH CHORDAL LOOPS, FREEING THE PRE-ATTACHED PLEDGET ADJACENT TO THE CHORDAL LOOPS. THE FOLLOW-UP QUESTION: ¿WHETHER THE PAPILLARY SUTURE PULLED OUT OF THE PAPILLARY OR WHETHER IT REMAINED (IN PART) ANCHORED TO THE PAPILLARY WHEN FAILURE OCCURRED¿ WAS POSED TO THE SALES REPRESENTATIVE HOWEVER NO FURTHER INFORMATION WAS PROVIDED BY THE SURGEON. WITHOUT RETURN OF THE PRODUCT, A MORE THOROUGH INVESTIGATION IS NOT POSSIBLE.

Additional Manufacturer Narrative

THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

Description of Event or Problem

DR (B)(6) IMPLANTED A 3-0, 24MM CHORD-X. AS HE WAS TYING THE 2ND SUTURE ON THE LEAFLET, HE FELT A SLIPPAGE OF THE SUTURE. UPON TYING THE 3RD SUTURE ON THE LEAFLET, THEN ENTIRE SUTURE BROKE AND PULLED OUT OF THE PAPILLARY MUSCLE. HE REMOVED THE REMAINING SUTURE AND FREE PLEDGET. HE THEN SPENT CONSIDERABLE TIME TRYING TO LOCATE THE PRE-ATTACHED PLEDGET WITHOUT SUCCESS. PATIENT IMPACT REPORTED AS SURGERY WAS PROLONGED APPROXIMATELY 90 MINUTES. A CHORDAL TRANSFER FROM P1 TO A1 WAS PERFORMED AND ANNULOPLASTY RING IMPLANTED. THE PRE-ATTACHED PLEDGET TO THE PAPILLARY SUTURE WAS NOT LOCATED. ADDITIONAL INFORMATION FROM THE REP INDICATED: ATTACHED IS THE RESPONSE FROM DR (B)(6) CONCERNING THE QUESTIONS FROM YOU AND (B)(6). "I DID NOT THINK THE SUTURE BROKE. I DO GET THE SENSE THAT THE PRE-TIED KNOTS SLID WHEN I DIDN'T EXPECT THEM TO. I CAN'T REALLY TELL WHAT HAPPENED AT THE LEVEL OF THE PAP, BUT THE THING CAME OUT WITH ONLY ONE PLEDGET, WHICH WOULD SUGGEST THAT THE SUTURE DID BREAK."