BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 3745619 · Received April 11, 2014

    Report

    Report Number
    1063481-2014-00015
    Event Type
    Injury
    Date Received
    April 11, 2014
    Report Date
    April 9, 2014
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE ARTICLE, "POTENTIAL MYOCARDIAL REGENERATION WITH CORMATRIX ECM: A CASE REPORT," PUBLISHED IN THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, A (B)(6) FEMALE PATIENT UNDERWENT 3-VESSEL CORONARY ARTERY BYPASS GRAFTING. SIX YEARS LATER THE PATIENT HAD AN ACUTE INFARCTION WITH VENTRICULAR RUPTURE. SHE UNDERWENT SUTURELESS REPAIR OF A FALSE ANEURYSM USING BIOGLUE CLOSURE OF THE LATERAL VENTRICULAR WALL. THE PATIENT REPORTED CHEST PAIN AND SYNCOPE. ANGIOGRAPHY REVEALED A SUPERFICIAL FALSE ANEURYSM (54X24MM) SUPERIMPOSED ON A DEEPER FALSE ANEURYSM (72X49MM). TRANSTHORACIC ECHOCARDIPGRAPHY DEMONSTRATED INFERIOR AND INFEROLATERAL HYPOKINESIS OF THE LEFT VENTRICLE (LEFT VENTRICULAR RJECTION FRACTION 20%-40%), VENTRICULAR DILATION (LEFT VENTRICULAR END-SYSTOLIC DIAMETER 39MM AND LEFT VENTRICULAR END-DIASTOLIC DIAMETER 53MM), MILD MITRAL REGURGITATION, AND LARGE FALSE ANEURYSMS. THE PATIENT THEN UNDERWENT CORMATRIX ECM FALSE ANEURYSM REPAIR WITH FEMORAL CANNULATION THROUGH A LEFT THORACOTOMY.MULTIPLE CONTACT ATTEMPTS TO REQUEST ADDITIONAL INFORMATION FROM THE AUTHORS OF THE PUBLICATION, INCLUDING INFORMATION ON THE FALSE ANEURYSMS REPAIR PROCEDURE IN WHICH BIOGLUE WAS USED AND THE CONDITION OF THE PATIENT'S NATIVE TISSUE. HOWEVER, NO RESPONSE WAS RECEIVED AND THEREFORE NO INFORMATION WAS OBTAINED.A REVIEW WAS PERFORMED ON THE AVAILABLE INFORMATION. THE CAUSE OF THE FALSE ANEURYSMS OBSERVED IN THE PATIENT COULD NOT BE DEFINITIVELY DETERMINED. THE PATIENT UNDERWENT A 3-VESSEL CABG PROCEDURE AND SUTURELESS FALSE ANEURYSM REPAIR UTILIZING BIOGLUE NINE AND THREE YEAR, RESPECTIVELY, PRIOR TO PRESENTING WITH CHEST PAIN AND SYNCOPE. ANGIOGRAPHY REVEALED A SUPERFICIAL FALSE ANEURYSM SUPERIMPOSED ON A DEEPER FALSE ANEURYSM; UPON SURGERY IT WAS DETERMINED THAT THE DEEPER FALSE ANEURYSM WAS THE "OLD" FALSE ANEURYSM ORIGINALLY REPAIRED USING BIOGLUE WITHOUT SUTURE. THE AUTHORS DO NOT SUGGEST THAT BIOGLUE MAY HAVE BEEN THE UNDERLYING CAUSE OF THE FALSE ANEURYSM. THE QUANTITY OF BIOGLUE USED AT THE INITIAL SURGERY IS UNKNOWN; HOWEVER, IT IS UNLIKELY THAT LITTLE, IF ANY, BIOGLUE REMAINED AT THE SURGICAL SITE THREE YEARS AFTER APPLICATION. WHILE ADDITIONAL INFORMATION IS REQUIRED TO MORE FULLY ASSESS THE OBSERVED COMPLICATION, BECAUSE THE EVENT OCCURRED THREE YEARS FOLLOWING THE PROCEDURE IN WHICH BIOGLUE WAS USED, IT IS NOT LIKELY THAT BIOGLUE CAUSED OR CONTRIBUTED TO THE OBSERVED EVENT.

    Additional Manufacturer Narrative · 1

    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 CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Description of Event or Problem · 1

    ACCORDING TO THE ARTICLE, "POTENTIAL MYOCARDIAL REGENERATION WITH CORMATRIX ECM: A CASE REPORT," PUBLISHED IN THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, A (B)(6) FEMALE PATIENT UNDERWENT 3-VESSEL CORONARY ARTERY BYPASS GRAFTING. SIX YEARS LATER, THE PATIENT HAD AN ACUTE INFARCTION WITH VENTRICULAR RUPTURE. SHE UNDERWENT SUTURELESS REPAIR OF A FALSE ANEURYSM USING BIOGLUE CLOSURE OF THE LATERAL VENTRICULAR WALL. THE PATIENT REPORTED CHEST PAIN AND SYNCOPE. ANGIOGRAPHY REVEALED A SUPERFICIAL FALSE ANEURYSM (54X24MM) SUPERIMPOSED ON A DEEPER FALSE ANEURYSM (72X49MM). TRANSTHORACIC ECHOCARDIOGRAPHY DEMONSTRATED INFERIOR AND INFEROLATERAL HYPOKINESIS OF THE LEFT VENTRICLE (LEFT VENTRICULAR EJECTION FRACTION 20%-40%), VENTRICULAR DILATION (LEFT VENTRICULAR END-SYSTOLIC DIAMETER 39MM AND LEFT VENTRICULAR END-DIASTOLIC DIAMETER 53MM), MILD MITRAL REGURGITATION, AND LARGE FALSE ANEURYSMS. THE PATIENT THEN UNDERWENT CORMATRIX ECM FALSE ANEURYSM REPAIR WITH FEMORAL CANNULATION THROUGH A LEFT THORACOTOMY.

    Description of Event or Problem · 1

    ACCORDING TO THE ARTICLE, "POTENTIAL MYOCARDIAL REGENERATION WITH CORMATRIX ECM: A CASE REPORT," PUBLISHED IN THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, A (B)(6) FEMALE PATIENT UNDERWENT 3-VESSEL CORONARY ARTERY BYPASS GRAFTING. SIX YEARS LATER THE PATIENT HAD AN ACUTE INFARCTION WITH VENTRICULAR RUPTURE. SHE UNDERWENT SUTURELESS REPAIR OF A FALSE ANEURYSM USING BIOGLUE CLOSURE OF THE LATERAL VENTRICULAR WALL. THE PATIENT REPORTED CHEST PAIN AND SYNCOPE. ANGIOGRAPHY REVEALED A SUPERFICIAL FALSE ANEURYSM (54X24MM) SUPERIMPOSED ON A DEEPER FALSE ANEURYSM (72X49MM). TRANSTHORACIC ECHOCARDIPGRAPHY DEMONSTRATED INFERIOR AND INFEROLATERAL HYPOKINESIS OF THE LEFT VENTRICLE (LEFT VENTRICULAR REJECTION FRACTION 20%-40%), VENTRICULAR DILATION (LEFT VENTRICULAR END-SYSTOLIC DIAMETER 39MM AND LEFT VENTRICULAR END-DIASTOLIC DIAMETER 53MM), MILD MITRAL REGURGITATION, AND LARGE FALSE ANEURYSMS. THE PATIENT THEN UNDERWENT CORMATRIX ECM FALSE ANEURYSM REPAIR WITH FEMORAL CANNULATION THROUGH A LEFT THORACOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223700 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MUQ CRYOLIFE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other