BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PRECLUDE® PERICARDIAL MEMBRANE

    MDR report key: 6032866 · Received October 16, 2016

    Report

    Report Number
    3003910212-2016-00058
    Event Type
    Injury
    Date Received
    October 16, 2016
    Date of Event
    April 2, 2005
    Report Date
    October 20, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DXZ
    PMA / PMN Number
    K012098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED ADDRESS OF MANUFACTURING SITE FOR DEVICES. UPDATED 510(K) NUMBER.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. THE CAUSE OF THE DEVICE INFECTION COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE. THE DEVICE WAS NOT RETURNED, THEREFORE NO FURTHER EVALUATION COULD BE CONDUCTED.

    Description of Event or Problem · 1

    IN A REVIEW OF PUBLISHED LITERATURE, THE FOLLOWING FINDINGS WERE NOTED: ATSUSHI TAMURA ET AL., "MEDIASTINITIS FOLLOWING GRAFT REPLACEMENT OF THE ASCENDING AND TOTAL ARCH AORTA IN TWO CASES" IN JAPANESE JOURNAL OF CARDIOVASCULAR SURGERY, VOL. 35, NO. 3, PAGE 147-150 (PUBLISHED IN MAY 2006). THE ARTICLE STATES THAT A GORE-TEX® (PRODUCT NAME NOT SPECIFIED) WAS USED IN ONE OF THE TWO CASES. ON (B)(6) 2004, THE PATIENT COMPLAINED OF BACK PAIN, AND VISITED THE NEAREST INSTITUTION, WHERE SHE WAS DIAGNOSED WITH A THORACIC AORTIC ANEURYSM, AND THEN HOSPITALIZED. ON (B)(6) 2005, THE PATIENT WAS TRANSFERRED TO THE (B)(6) MEDICAL CENTER. CT IMAGES CONFIRMED THAT THE ASCENDING AORTA WAS HIGHLY CALCIFIED, AND THAT ANEURYSMS DEVELOPED WITH DIAMETER OF 60MM AT THE DISTAL AORTIC ARCH, AND WITH DIAMETER OF 50MM AT THE INFRARENAL ABDOMINAL AORTA. IT WAS ALSO CONFIRMED THAT THE DESCENDING AORTA WAS SHAGGY. ON (B)(6) 2005, THE PATIENT UNDERWENT FIRST STAGE REPLACEMENT SURGERY OF THE ASCENDING AND TOTAL ARCH AORTA USING A SURGICAL GRAFT OF ANOTHER MANUFACTURER. IT WAS REPORTED THAT A GORE-TEX® (PRODUCT NAME NOT SPECIFIED) PATCH WAS USED DURING THE SURGERY TO CLOSE THE PERICARDIUM. ON (B)(6) 2005, THE PATIENT UNDERWENT SECOND STAGE REPLACEMENT SURGERY OF THE ABDOMINAL AORTA USING ANOTHER SURGICAL GRAFT OF ANOTHER MANUFACTURER. POST-OPERATIVELY, THE PATIENT WAS DOING WELL. ON (B)(6) 2005, THE PATIENT DEVELOPED ILEUS, AND WAS TREATED WITH MEDICINE (DETAIL OF THE MEDICINE NOT STATED). THE PATIENT WAS REPORTED TO BE RECOVERING FROM THE ILEUS, AND THE PATIENT'S CRP LEVEL BECAME NORMAL. ON (B)(6) 2005, THE PATIENT COMPLAINED OF REDNESS AND SWELLING AT THE THORACIC INCISION. THE INCISION WAS DRAINED AND THE SUBSEQUENT DRAINAGE CULTURE IDENTIFIED PSEUDOMONAS AERUGINOSA. THE PATIENT'S CRP LEVEL REMAINED HIGH AT THIS TIME, WHILE NO FEVER OR INCREASE OF WHITE BLOOD CELLS WERE SEEN. THE RESULT OF THE BLOOD CULTURE WAS REPORTED TO BE NEGATIVE. ON (B)(6) 2005, THE GORE-TEX® USED DURING THE THORACIC AORTA REPLACEMENT COULD BE VISUALLY CONFIRMED FROM THE THORACIC INCISION. THE PATIENT WAS DIAGNOSED MEDIASTINITIS, AND STARTED TREATMENT WITH IMIPENEM. CT IMAGES CONFIRMED THAT THE INFECTION WAS FOCAL AROUND THE THORACIC INCISION AND DID NOT REACH THE SURGICAL GRAFT, THEREFORE DETERMINED THAT THE INFECTED AREA WAS BETWEEN THE INCISION AND ANTERIOR TO THE GORE-TEX ON (B)(6) 2005, THE PATIENT UNDERWENT A RE-INTERVENTION TO TREAT THE INFECTION, WHEREAS THE GORE-TEX® WAS REMOVED, AND DEBRIDEMENT PERFORMED. THE RE-OPENED THORACIC INCISION WAS DETERMINED TO LEAVE OPEN, AND IRRIGATION WITH IODINE SOLUTION WAS UNDERTAKEN FOR SIX DAYS. DRAINAGE CULTURE PERFORMED ON THE SAME DAY DETECTED PSEUDOMONAS AERUGINOSA; HOWEVER THE SUBSEQUENT CULTURES RESULTED NEGATIVE. ON (B)(6) 2005, THE RE-OPENED INCISION WAS CLOSED AS PLANNED, AND PECTORALIS MAJOR MUSCLE PLOMBAGE WAS PERFORMED. POST-OPERATIVELY THE PATIENT WAS DOING WELL, AND DISCHARGED FROM THE INSTITUTION ON (B)(6) 2005. NO RECURRENCE OF THE INFECTION WAS REPORTED. THE CAUSE OF THE INFECTION WAS NOT REPORTED IN THE LITERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683882 GORE PRECLUDE® PERICARDIAL MEMBRANE PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R