BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-X ASCENDING AORTIC PROSTHESIS

    MDR report key: 5996698 · Received October 4, 2016

    Report

    Report Number
    1649833-2016-00061
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    August 17, 2016
    Report Date
    December 14, 2016
    Manufacturer
    CRYOLIFE, INC. ¿ AUSTIN
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: BRAND NAME UPDATED TO ASCENDING AORTIC PROSTHESIS / MODEL #/LOT # UPDATED WITH SERIAL NUMBER, UDI, AND CORRECT PRODUCT CODE / MFR SITE UPDATED TO ON-X LIFE TECHNOLOGIES INC THE FOLLOWING ADDITIONAL INFORMATION WAS REQUESTED ON 09/13/2016: CLARIFICATION IF THE SURGEON IS REFERRING TO THE SEWING RING WHEN HE IS STATING "CUFF ON THE ROOT" AND "COMPOSITE ROOT,¿ DETAILS REGARDING IMPLANT TECHNIQUE AND SUTURING, INDICATION FOR PROCEDURE AND PERTINENT PATIENT COMORBIDITIES, INR/COAGULATION METHODS, IF THE PATIENT REMAINED STABLE THROUGHOUT PROCEDURE, CURRENT PATIENT STATUS, AND IF IMPLANT/OPERATIVE NOTES WERE AVAILABLE. ADDITIONALLY, DETAILS WERE REQUESTED REGARDING THE OTHER ALLEGATIONS OF SIMILAR OCCURRENCES REPORTED (INCLUDING DATE OF EVENTS, SN, INDICATION FOR PROCEDURES AND PATIENT COMORBIDITIES, RESULTANT PATIENT IMPACT) ON THOSE EVENTS SO EACH COULD BE INVESTIGATED SEPARATELY. THE REP RESPONDED ON 09/19/2016, ¿YES THE SURGEON IS REFERRING TO THE SEWING RING WHEN STATING ¿THE CUFF ON THE ROOT IS VERY POROUS¿ AND ALSO WHEN HE REFERS TO THIS HAPPENING ON THREE OR MORE OCCASIONS. HE IS ONLY REFERRING TO THE SEWING RING NOT THE GEL WEAVE VALSALVA. IMPLANT TECHNIQUE AND SUTURING DETAILS HE GAVE ME AS - CONTINUOUS #2 PROLENE SUTURE. INDICATION FOR PROCEDURE AND PERTINENT PATIENT COMORBIDITIES - AORTIC ROOT REPLACEMENT AND NO PATIENT COMORBIDITIES. INR/COAGULATION - NOT APPLICABLE SURGEON SAID. DID THE PATIENT REMAIN STABLE THROUGHOUT THE PROCEDURE ¿ YES. CURRENT PATIENT STATUS - HOME, FINE. ARE IMPLANT/ OPERATIVE NOTES AVAILABLE - NO, THIS IS FOR PATIENT CONFIDENTIALITY SO NOT AVAILABLE TO A PUBLIC COMPANY THE SURGEON SAID UNLESS THE PATIENT WAS ASKED AND PERMISSION WAS GIVEN BY THE PATIENT.¿ ADDITIONAL INFORMATION RECEIVED CONFIRMED ONLY ONE OTHER SIMILAR INCIDENT WITH THE AAP HAS OCCURRED AS EXPERIENCED BY THE SURGEON. THIS SEPARATE EVENT WILL BE INVESTIGATED SEPARATELY. THE MANUFACTURING RECORDS FOR THE ONXAAP-27/29, SN (B)(4), 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. THE ONXAAP-27/29, SN (B)(4), WAS IMPLANTED (B)(6) 2016 IN THE AORTIC POSITION. THE SURGEON OBSERVED "OOZING AROUND THE CUFF' WHICH STOPPED AFTER THE ADMINISTRATION OF PROTAMINE (A DRUG REVERSING THE ANTICOAGULANT EFFECTS OF HEPARIN). THE LOCATION OF OOZING WAS DESCRIBED AS THE SEWING RING PART OF THE AAP THAT WAS POROUS AND NOT THE GEL WEAVE VALSALVA. THE SURGEON USED A CONTINUOUS #2 POLYPROPYLENE SUTURE TECHNIQUE. OOZING THROUGH THE CUFF IS NOT A PREVIOUSLY REPORTED OBSERVATION, BUT THIS SURGEON CLAIMS TO HAVE SEEN IT ON THREE OR MORE OCCASIONS. THE SOURCE OF "OOZING" IS MORE LIKELY RELATED TO THE SUTURE TECHNIQUE. THE INSTRUCTIONS FOR USE (IFU) FOR THE AAP NOTES THAT "THE GENERAL CONSENSUS AMONG SURGEONS IS THAT A NON-EVERTING INTERRUPTED MATTRESS SUTURE TECHNIQUE, WITH OR WITHOUT PLEDGETS, PROVIDES THE BEST CONFORMATION OF THE VALVE ANNULUS TO THE OUTER SURFACE OF THE FLARE."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORT FROM THE SURGEON, HE STATED "THE CUFF ON THE ROOT IS VERY PORUS AND LEAKS CONSIDERABLY. MORE SO THAN OTHER ROOTS. I HAVE HAD THIS HAPPEN ON 3 OR MORE OCCASIONS WITH THE ON-X COMPOSITE ROOT." ADDITIONAL INFORMATION FROM THE REP INDICATED THAT THE SURGEON HAS ONLY PERFORMED ONE AAP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647804 ON-X ASCENDING AORTIC PROSTHESIS HEART-VALVE, MECHANICAL LWQ CRYOLIFE, INC. ¿ AUSTIN ONXAAP-27/29 5219807

    Patients

    Seq Age Sex Outcome Treatment
    1