BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOVALVE AORTIC VALVE AND CONDUIT

    MDR report key: 5577339 · Received April 14, 2016

    Report

    Report Number
    1063481-2016-00043
    Event Type
    Injury
    Date Received
    April 14, 2016
    Date of Event
    November 26, 1999
    Report Date
    April 8, 2016
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    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

    (B)(6). ACCORDING TO REPORT AND CASE REPORT FORMS (CRFS) FOR PATIENT (B)(6) ((B)(6) STUDY) WAS IMPLANTED WITH AORTIC VALVE AND CONDUIT (AV00, SID (B)(4), DONOR (B)(6)) ON (B)(6) 1999 AND EXPERIENCED "PERSISTENT POST-OP BLEEDING; IMMEDIATE INTRA/POST-OP COAGULOPATHY CORRECTED BUT CONTINUED TO BLEED; REOPERATION [ON (B)(6) 1999] FOUND CLOTS AND SEVERAL SMALL BLEEDING SITES AND PERSISTENT COAGULOPATHY." BOTH THE CRFS CAN BE FOUND UNDER THE MEDICAL RECORDS TAB FOR REFERENCE. THE CRFS RECORD THE FOLLOWING: PRE-OPERATIVE DIAGNOSIS/INDICATION FOR AVR ON (B)(6) 1999 (AORTIC VALVE REPLACEMENT): ACUTE ASCENDING AORTIC DISSECTION. ACUTE DISSECTION OCCURRED OUTSIDE FACILITY. CALLED 911 FOR "C/O LUE AND RLE [COMPLAINS OF LEFT UPPER EXTREMITY AND RIGHT LOWER EXTREMITY] SYMPTOMS THOUGHT TO BE CVA [CEREBROVASCULAR ACCIDENT]; FLOWN VIA LIFE FORCE TO ERLANGER." EMERGENT PROCEDURE. UNDERWENT TIME OF CONCOMITANT PROCEDURES AT TIME OF AVR: AORTIC ARCH REPLACEMENT (REPAIR OF EXTENSIVE ASCENDING AORTA DISSECTION), REDUCTION AORTOPLASTY, RESECTION OF ASCENDING AORTIC ANEURYSM. PRE-OPERATIVE RISK FACTORS: ALCOHOL USE. INTERVENTION PERFORMED (B)(6) 1999: MEDIASTINUM EXPLORATION FOR POST-OP BLEEDING. "FOUND CLOTS AND SEVERAL SMALL BLEEDING SITES AND PERSISTENT COAGULOPATHY." "ALSO COMPLICATED POST-OP COURSE INVOLVING ACUTE RENAL FAILURE DUE TO ACUTE TUBULAR NECROSIS, ON HEMODIALYSIS COAGULOPATHY, THROMBOCYTOPENIA, GI BLEED AND LEFT GROIN INFECTION WITH POSITIVE CULTURE FORM GRAM NEGATIVE RODS." A REVIEW OF TISSUE PROCESSING WAS PERFORMED. ALLOGRAFT (B)(4) WAS NOT RETURNED TO CRYOLIFE SO NO DIRECT OBSERVATIONS CAN BE MADE. DURING THE INSPECTION OF EACH CARDIAC ALLOGRAFT, A QUALIFIED TECHNICIAN WEARING SURGICAL LOUPES INSPECTS THE ALLOGRAFT FOR ATTRIBUTES SUCH AS PLAQUE, TEARS, ETC. PER PROCEDURE. THIS ALLOGRAFT WAS PROCESSED FROM THE HEART OF A (B)(6), (B)(6) FEMALE WHO DIED FROM MYOCARDIAL INFARCTION. THE ALLOGRAFT WAS INSPECTED ON (B)(6) 1999 BY (B)(6). THE INSPECTOR NOTED THE FOLLOWING ATTRIBUTES: "SPICULES PSC [POSTERIOR SEMILUNAR CUSP. SPICULE RSC [RIGHT SEMILUNAR CUSP]. FIBROUS THICKENING LSC [LEFT SEMILUNAR CUSP]. LIGHT PLAQUE AT ANNULUS OF ALL LEAFLETS. MODERATE PLAQUE AML [ANTERIOR MITRAL LEAFLET] AND IN CONDUIT. TRANSECTED PROXIMAL TO SUBCLAVIAN ARTERY. ABERRANT VESSEL DISTAL TO CAROTID ARTERY. BULBOUS SINUSES." THE CERTIFICATE OF ASSURANCE WAS REVIEWED. ALL ATTRIBUTES IDENTIFIED AT INSPECTION WERE DOCUMENTED APPROPRIATELY. NO ATTRIBUTES WERE NOTED THAT WOULD HAVE REJECTED THIS ALLOGRAFT. A REVIEW OF TRAINING RECORDS INDICATES THAT THE TECHNICIAN WHO INSPECTED THIS ALLOGRAFT WAS APPROPRIATELY TRAINED FOR THE TASK SHE PERFORMED. STUDY PATIENT (B)(6) UNDERWENT HOMOGRAFT IMPLANT VIA FULL CONVENTIONAL STERNOTOMY WITH CONCOMITANT AORTIC ARCH REPLACEMENT, REDUCTION OF AORTOPLASTY, AND RESECTION OF ASCENDING AORTIC ANEURYSM AT (B)(6) YEARS OF AGE ((B)(6) 1999). THE INDICATION FOR AORTIC VALVE REPLACEMENT WAS ACUTE ASCENDING AORTIC DISSECTION INCLUDING AN 8 CM AORTIC ANEURYSM LOCATED IN THE AORTIC ARCH, AORTIC ROOT, ASCENDING AORTA, AND TO THE LEVEL OF RENAL ARTERIES. THE SITE NOTED, "ACUTE DISSECTION OCCURRED OUTSIDE FACILITY; CALLED 911 FOR C/O LUE AND RLE SYMPTOMS THOUGHT TO BE CVA; FLOWN VIA LIFE FORCE TO (B)(6)." THE PATIENT'S PRE­ OPERATIVE RISK FACTORS INCLUDED ALCOHOL USE. ON (B)(6) 1999 THE PATIENT REQUIRED MEDIASTINUM REOPERATION AND EXPLORATION DUE TO "PERSISTENT POST-OP BLEEDING; IMMEDIATE INTRA/POST OP COAGULOPATHY CORRECTED BUT CONTINUED TO BLEED. RE­EXPLORATION FOUND CLOTS AND 'SEVERAL SMALL BLEEDING SITES' AND PERSISTENT COAGULOPATHY." INFORMATION FROM CRFS STATED THE "POST-OP COURSE WAS COMPLICATED DUE TO ACUTE RENAL FAILURE DUE TO ACUTE TUBULAR NECROSIS, ON HEMODIALYSIS, COAGULOPATHY, THROMBOCYTOPENIA, GI BLEED AND LEFT GROIN INFECTION WITH POSITIVE CULTURE FOR GRAM NEGATIVE RODS." THE DETAILS REGARDING THE LOCATION OF THE BLEEDING ARE UNKNOWN; HOWEVER, THE DESCRIPTION OF SEVERAL SMALL BLEEDING SITES IS CONSISTENT WITH BLEEDING SECONDARY TO A COAGULOPATHY. THERE IS NO EVIDENCE TO SUGGEST THAT THE BLEEDING WAS RELATED TO THE ALLOGRAFT. BLEEDING FOLLOWING AORTIC VALVE REPLACEMENT HAS BEEN REPORTED IN THE LITERATURE (BEKKERS, 2011; DAGENAIS, 2005; DOSSCHE, 1999). A SIMILAR RATE OF THE BLEEDING POST OPERATIVELY HAS BEEN REPORTED ACROSS DIFFERENT VALVES USED FOR AORTIC VALVE REPLACEMENT (DAGENAIS, 2005). OLDER AGE AT IMPLANT, CONCOMITANT PROCEDURES, AND EMERGENT INDICATION, HAVE BEEN REPORTED AS POTENTIAL RISK FACTORS FOR POST-OPERATIVE BLEEDING (DAGENAIS, 2005; STAMOU, 2015; SVENSSON, 2013). THE EVENT UNDER REVIEW INCLUDED TWO OF THE THREE RISK FACTORS. THE ROOT CAUSE FOR THE REPORTED EVENT IS MOST LIKELY A COAGULOPATHY RELATED TO THE SURGERY AND CARDIOPULMONARY BYPASS.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, PATIENT (B)(6) IMPLANTED WITH AORTIC VALVE AND CONDUIT ALLOGRAFT ON (B)(6) 1999, PROCEDURE INDICATED FOR ACUTE ASCENDING AORTIC DISSECTION. CONCOMITANT PROCEDURES AT TIME OF AVR: AORTIC ARCH REPLACEMENT (REPAIR OF EXTENSIVE ASCENDING AORTA DISSECTION), REDUCTION AORTOPLASTY, RESECTION OF ASCENDING AORTIC ANEURYSM. PRE-OPERATIVE RISK FACTORS: ALCOHOL USE. PRE-OPERATIVE COEXISTING CARDIAC CONDITIONS: AORTIC ANEURYSM: AORTIC ARCH, AORTIC ROOT, ASCENDING AORTA, OTHER - TO LEVAL OF RENAL ARTERIES. AORTIC ANEURYSM SIZE 8CM. AORTIC DISSECTION. ON (B)(6) 1999 "PERSISTENT POST-OP BLEEDING; IMMEDIATE INTRA/POST-OP COAGULOPATHY CORRECTED BUT CONTINUED TO BLEED; REOPERATION FOUND CLOTS AND SEVERAL SMALL BLEEDING SITES AND PERSISTENT COAGULOPATHY."

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, PATIENT (B)(6) IMPLANTED WITH AORTIC VALVE AND CONDUIT ALLOGRAFT ON (B)(6) 1999, PROCEDURE INDICATED FOR ACUTE ASCENDING AORTIC DISSECTION. CONCOMITANT PROCEDURES AT TIME OF AVR: AORTIC ARCH REPLACEMENT (REPAIR OF EXTENSIVE ASCENDING AORTA DISSECTION), REDUCTION AORTOPLASTY, RESECTION OF ASCENDING AORTIC ANEURYSM. PRE-OPERATIVE RISK FACTORS: ALCOHOL USE. PRE-OPERATIVE COEXISTING CARDIAC CONDITIONS: AORTIC ANEURYSM: AORTIC ARCH, AORTIC ROOT, ASCENDING AORTA, OTHER - TO LEVEL OF RENAL ARTERIES. AORTIC ANEURYSM SIZE 8CM. AORTIC DISSECTION. ON (B)(6) 1999 "PERSISTENT POST-OP BLEEDING; IMMEDIATE INTRA/POST-OP COAGULOPATHY CORRECTED BUT CONTINUED TO BLEED; REOPERATION FOUND CLOTS AND SEVERAL SMALL BLEEDING SITES AND PERSISTENT COAGULOPATHY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234233 CRYOVALVE AORTIC VALVE AND CONDUIT HUMAN HEART ALLOGRAFT MIE CRYOLIFE, INC. AV00 4284645, DONOR 43351

    Patients

    Seq Age Sex Outcome Treatment
    1 63.2 YR Hospitalization| O| R