CHORDX 2-0 SUT 18MM 3/8CIR 20MM LOOP

Additional Manufacturer Narrative

THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

Description of Event or Problem

ACCORDING TO THE INITIAL REPORT, AFTER IMPLANT OF THIS CHORD-X DEVICE, IT WAS DISCOVERED THAT THE PAPILLARY STITCH/ARM HAD BEEN CUT/SEVERED AND RELEASED FROM THE PAPILLARY MUSCLE. SURGEON STATED THEY COULD NOT FIND THE PLEDGET THAT SLIPPED OFF THE BROKEN PAPILLARY ANCHOR AND BELIEVED IT MUST HAVE BEEN LOST IN THE PATIENT'S LEFT VENTRICLE.

Additional Manufacturer Narrative

THE MANUFACTURING RECORDS FOR CXL-20-1838-20 LOT Z226008100 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. DURING THE INVESTIGATION NO NON-CONFORMANCES OR DEVIATIONS WERE NOTED. ACCORDING TO THE CHORD-X IFU (INSTRUCTIONS FOR USE) IT IS SPECIFICALLY RECOMMENDED : ¿AS WITH ANY SUTURE, CARE SHOULD BE TAKEN TO AVOID DAMAGE WHEN HANDLING. AVOID CRUSHING OR CRIMPING THE SUTURE WITH SURGICAL INSTRUMENTS OR EXPOSING THE SUTURE TO SHARP EDGES, WHICH MAY ADVERSELY AFFECT THE TENSILE STRENGTH OF THE SUTURE. AVOID USING KNOT PUSHERS WITH IMPERFECTIONS SUCH AS BURRS OR FLASHING WHICH MAY DAMAGE THE SUTURE.¿ AS THE SURGEON DESCRIBED IN THIS CASE OF CHORD DETACHMENT, SHE USED METAL KNOT PUSHERS TO TIE DOWN THE PAPILLARY STITCH AND DURING THE IN-SERVICE IT WAS RELAYED AND SHE AGREED THAT FINGER TYING WOULD BE A BETTER PROCEDURE VS. USING METAL KNOT PUSHERS. THE ROOT CAUSE OF THE CHORD-X SYSTEM DETACHING FROM THE PAPILLARY MUSCLE IS MOST LIKELY THE USE OF THE METAL KNOT PUSHERS THAT MAY HAVE HAD BURRS OR FLASHING THAT ADVERSELY AFFECTED THE TENSILE STRENGTH OF THE CHORD-X SUTURE. THE CORRECTIVE ACTION WAS TO PERFORM THE IN-SERVICE AND WET LAB FOR THE SURGEON AND STAFF, THIS WAS SUCCESSFULLY ACCOMPLISHED AS EVIDENCED BY THE SURGEON AND TEAM SUCCESSFULLY PERFORMING AN ANTERIOR MITRAL REPAIR DURING THE WET LAB. THEY WERE ALSO GIVEN RESOURCES AND CONTACT INFORMATION FOR FURTHER QUESTIONS. RISK HAS BEEN REDUCED AS LOW AS POSSIBLE AND OVERALL RESIDUAL RISK IS ACCEPTABLE. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION. REFERENCES: ON-X CHORD-X PRE-MEASURED LOOPS AND SUTURE SYSTEM IFU HTTP://WWW.ONXLTI.COM/IFU.

Description of Event or Problem

ACCORDING TO THE INITIAL REPORT, AFTER IMPLANT OF THIS CHORD-X DEVICE, IT WAS DISCOVERED THAT THE PAPILLARY STITCH/ARM HAD BEEN CUT/SEVERED AND RELEASED FROM THE PAPILLARY MUSCLE. SURGEON STATED THEY COULD NOT FIND THE PLEDGET THAT SLIPPED OFF THE BROKEN PAPILLARY ANCHOR AND BELIEVED IT MUST HAVE BEEN LOST IN THE PATIENT'S LEFT VENTRICLE.