BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 3406553 · Received October 11, 2013

    Report

    Report Number
    2950727-2013-00055
    Event Type
    Death
    Date Received
    October 11, 2013
    Date of Event
    October 8, 2011
    Report Date
    November 7, 2013
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, THE PATIENT WAS A 70 YEAR OLD MALE WITH RECURRENT CLASS III ANGINA ON MAXIMUM ANTI-ANGINAL THERAPY. THE TMR PROCEDURE WAS PERFORMED ON (B)(6) 2011 WITH 23 CHANNELS PLACED; THE PATIENT TOLERATED THE PROCEDURE WELL. POST-PROCEDURE THE PATIENT EXPERIENCED ELEVATED SERUM CREATININE, ACUTE LETHARGY, PLEURAL EFFUSION, AND PULMONARY EDEMA; HE WAS DISCHARGED IN STABLE CONDITION ON POST-OP DAY 7. THE PATIENT HAD FIVE HOSPITALIZATIONS FROM THE TIME OF INDEX HOSPITALIZATION DISCHARGE UNTIL THE FINAL 6-MONTH FOLLOW-UP. THREE OUT OF THE FIVE WERE FOR RECURRENT CHEST PAIN WHICH WERE CONSIDERED ANGINA; HOWEVER, CARDIAC ENZYMES, EKGS, CXRS WERE ALL WITHIN NORMAL LIMITS. THE REMAINING TWO HOSPITALIZATIONS WERE FOR CONDITIONS RELATED TO THE PATIENT'S LABILE DIABETES. THE FIRST COMPLAINT OF CHEST DISCOMFORT DID NOT OCCUR UNTIL GREATER THAN 6 WEEKS POST-TMR PROCEDURE. THE PATIENT EXPIRED ON (B)(6) 2011, 179 DAYS POST-ENROLLMENT. THE CAUSE OF DEATH IS UNKNOWN AND THE DEATH CERTIFICATE UNOBTAINABLE. A REVIEW OF AVAILABLE RECORDS WAS PERFORMED FOR THIS EVENT. THE TMR PROCEDURE APPEARED TO PERFORM AS EXPECTED IN THE IMMEDIATE POST-OPERATIVE PERIOD AS THE PATIENT REPORTED AN INITIAL DRAMATIC RELIEF IN ANGINA SYMPTOMS. THE PATIENT'S CT SCAN SHOWED MULTI-VESSEL CORONARY ARTERY DISEASE WHICH PLACES THE PATIENT AT A SIGNIFICANTLY INCREASED RISK FOR SUDDEN CARDIAC DEATH. STUDY DATA HAS SHOWN SIMILAR 1-YEAR MORTALITY OUTCOMES BETWEEN TMR TREATED AND MEDICALLY TREATED ANGINA PATIENTS ((B)(4)). THIS WOULD SUGGEST THAT TMR DOES NOT SIGNIFICANTLY DECREASE THE RISK FOR SUDDEN CARDIAC DEATH WITHIN THE FIRST YEAR AS COMPARED TO MEDICAL TREATMENT ALONE. THEREFORE, SUDDEN CARDIAC DEATH IN PATIENTS WITH SEVERE CORONARY ARTERY DISEASE UNDERGOING TMR MAY OCCUR. HOWEVER, THIS IS AN INHERENT RISK RELATED TO THE UNDERLYING DISEASE AND NOT THE TMR PROCEDURE.

    Description of Event or Problem · 1

    ACCORDING TO THE STUDY, THE PATIENT WAS A (B)(6) MALE WITH RECURRENT CLASS III ANGINA ON MAXIMUM ANTI-ANGINAL THERAPY. THE PATIENT ENROLLED IN THE (B)(6) STUDY ON (B)(6) 2011 AND THE TMR PROCEDURE WAS PERFORMED ON (B)(6) 2011 WITH 23 CHANNELS PLACED; THE PATIENT TOLERATED THE PROCEDURE WELL. POST-PROCEDURE THE PATIENT EXPERIENCED ELEVATED SERUM CREATININE, ACUTE LETHARGY, PLEURAL EFFUSION, AND PULMONARY EDEMA; HE WAS DISCHARGED IN STABLE CONDITION ON POST-OP DAY 7. THE PATIENT HAD FIVE HOSPITALIZATIONS FROM THE TIME OF INDEX HOSPITALIZATION DISCHARGE UNTIL THE FINAL 6-MONTH FOLLOW-UP. THREE OUT OF THE FIVE WERE FOR RECURRENT CHEST PAIN WHICH WERE CONSIDERED ANGINA; HOWEVER, CARDIAC ENZYMES, EKGS, CXRS WERE ALL WNL. THE REMAINING TWO HOSPITALIZATIONS WERE FOR CONDITIONS RELATED TO THE PATIENT'S LABILE IDDM. THE FIRST COMPLAINT OF CHEST DISCOMFORT DID NOT OCCUR UNTIL GREATER THAN 6 WEEKS POST-TMR PROCEDURE. THE PATIENT EXPIRED ON (B)(6) 2011, 179 DAYS POST-ENROLLMENT. THE CAUSE OF DEATH IS UNKNOWN AND THE DEATH CERTIFICATE UNOBTAINABLE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE PATIENT WAS A (B)(6) MALE WITH RECURRENT CLASS III ANGINA ON MAXIMUM ANTI-ANGINAL THERAPY. THE TMR PROCEDURE WAS PERFORMED ON (B)(6) 2011 WITH 23 CHANNELS PLACED; THE PATIENT TOLERATED THE PROCEDURE WELL. POST-PROCEDURE THE PATIENT EXPERIENCED ELEVATED SERUM CREATININE, ACUTE LETHARGY, PLEURAL EFFUSION, AND PULMONARY EDEMA; HE WAS DISCHARGED IN STABLE CONDITION ON POST-OP DAY 7. THE PATIENT HAD FIVE HOSPITALIZATIONS FROM THE TIME OF INDEX HOSPITALIZATION DISCHARGE UNTIL THE FINAL 6-MONTH FOLLOW-UP. THREE OUT OF THE FIVE WERE FOR RECURRENT CHEST PAIN WHICH WERE CONSIDERED ANGINA; HOWEVER, CARDIAC ENZYMES, EKGS, CXRS WERE ALL WITHIN NORMAL LIMITS. THE REMAINING TWO HOSPITALIZATIONS WERE FOR CONDITIONS RELATED TO THE PATIENT'S LABILE DIABETES. THE FIRST COMPLAINT OF CHEST DISCOMFORT DID NOT OCCUR UNTIL GREATER THAN 6 WEEKS POST-TMR PROCEDURE. THE PATIENT EXPIRED ON (B)(6) 2011, 179 DAYS POST-ENROLLMENT. THE CAUSE OF DEATH IS UNKNOWN AND THE DEATH CERTIFICATE UNOBTAINABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522874 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL LASER REVASCULARIZATION HANDPIECE MNO CARDIOGENESIS CORPORATION HP-SG3 TA-03759

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| H