BEUDAMED
    FDA Adverse Event Death Summary report: N

    PCO VENTRAL PATCH 8C

    MDR report key: 5599237 · Received April 22, 2016

    Report

    Report Number
    9615742-2016-00020
    Event Type
    Death
    Date Received
    April 22, 2016
    Date of Event
    October 13, 2015
    Report Date
    April 19, 2016
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K110816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE NUMBER: (B)(4). BASED ON INFORMATION RECEIVED FROM THE IMPLANT PHYSICIAN AND A MEDICAL REPORT FROM THE TREATING PHYSICIAN AT THE TIME OF THE PATIENT'S PASSING, THE CAUSE OF DEATH WAS DETERMINED TO BE ORGAN FAILURE, PROGRESSIVE MENTAL DETERIORATION AND SEPTIC SHOCK UNRELATED TO THE IMPLANT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) HAS BEEN PERFORMED AND CONFIRMED THAT THIS LOT OF PRODUCTS WAS RELEASED ACCORDING TO QUALITY SPECIFICATIONS. THERE WERE NO NON-CONFORMANCES DURING THE MANUFACTURE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND THIS REVIEW CONFIRMED THAT THIS LOT OF PRODUCTS WAS REVIEWED AND RELEASED ACCORDING TO QA SPECIFICATIONS. NO ANOMALY WAS FOUND. NO PRODUCT AND NO PICTURE WERE PROVIDED FOR EVALUATION. WITHOUT THE SAMPLE A DETAILED INVESTIGATION COULD NOT BE PERFORMED. ACCORDING TO THE PRINCIPAL INVESTIGATOR, THIS WAS NOT CONSIDERED AN UNANTICIPATED ADVERSE DEVICE EFFECT AND THE EVENT DID NOT HAVE ANY RELATIONSHIP TO THE DEVICE. TO DATE, NO OTHER CASE OF DEATH HAS BEEN REPORTED ON THE PARIETEX COMPOSITE VENTRAL PATCH MESHES. THE REPORT HAS BEEN ADDED TO OUR PRODUCT COMPLAINTS DATABASE WHICH IS MONITORED FOR SIMILAR OCCURRENCES. BASED ON OUR INVESTIGATION AND A COMPLAINT HISTORY REVIEW, THE MANUFACTURE OF THE DEVICE IS NOT SUSPECTED. THERE IS NO INDICATION THAT THERE IS A DEFECTIVE LOT OR THAT THIS EVENT REPRESENTS AN EMERGING ADVERSE QUALITY TREND. THE EVENT DID NOT HAVE ANY RELATIONSHIP TO THE DEVICE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR. THE PATIENT DID NOT RETURN FOR HIS 6- AND 12-MONTH FOLLOW-UP VISITS. THE SITE ATTEMPTED TO CONTACT THE PATIENT SEVERAL TIMES VIA PHONE CALL AND A LETTER. THE GENERAL PHYSICIAN WAS ALSO CONTACTED WITH NO MORE INFORMATION MADE AVAILABLE. THE PATIENT WAS KEPT AS PART OF THE STUDY (REGARDLESS OF MISSED FOLLOW-UP) PER PROTOCOL. ALL PHYSICAL EVALUATIONS TO THAT POINT IN TIME REVEALED NORMAL FINDINGS. THERE WAS NO RECURRENCE OF HERNIA. CONTACT ATTEMPTS CONTINUED UNTIL THE 24-MONTH COMPLETION POINT. INFORMATION RECEIVED FROM ANOTHER FACILITY INDICATED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2015 WITH A HISTORY OF A HERNIA RECOVERY FROM AN UMBILICAL HERNIA REPAIR ON (B)(6) 2013. CARDIOLOGY READINGS WERE PERFORMED FOLLOWING COMPLAINTS OF LIGHTHEADEDNESS AND CHAIN PAIN. AN ANGIOGRAPH WAS PERFORMED WITH NEGATIVE FINDINGS. A CT OF THE THORAX WAS NORMAL. CARDIAC CATHETERIZATION RETURNED NORMAL FINDINGS. THE PATIENT WAS ADMITTED DUE TO SEPTIC SHOCK, PROGRESSIVE CONFUSION AND A FAST-MOVING NEUROLOGICAL DETERIORATION. THE PATIENT WAS INTUBATED AND VENTILATED. ANTIBIOTICS WERE STARTED IN THE EMERGENCY ROOM AND CONTINUED. THERE WAS ALSO CLINICAL JAUNDICE, ACUTE RENAL INSUFFICIENCY, "PERIODIC STATE OF THE EYES" AND SEPTIC EDEMA TO THE FINGERS AND TOES. ENDOCARDITIS WAS SUSPECTED AND CONFIRMED WITH ECHOCARDIOGRAPHIC TESTS. THERE WAS EXTENSIVE VEGETATION BOTH IN THE AORTIC, MITRAL AND TRICUSPID VALVES. FROM THE BLOOD CULTURE, THERE WAS GROWTH OF STAPHYLOCOCCUS AUREUS WITH DIRECT ADJUSTMENT OF THE ANTIBIOTICS. IN THE DAYS FOLLOWING, THERE WAS PROGRESSIVE DETERIORATION. NEUROLOGICALLY, THE SUBSEQUENT FOLLOW-UP WAS ADDED: NO IMPROVEMENT WITH PERSISTENT STATE OF NEAR UNCONSCIOUSNESS, COMMENTS AND ABSENCE OF LIMB MOVEMENT. GIVEN THIS POOR NEUROLOGICAL CONDITION, THE PROGRESSIVE SEPTIC SHOCK, THE EXTENSIVE VEGETATION ON 3 HEART VALVES, THE LIVER AND KIDNEY FAILURE, IT WAS CONCLUDED THAT SURGERY WAS NOT POSSIBLE. THE PATIENT EXPIRED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253661 PCO VENTRAL PATCH 8C MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION PCO8VP PNC0434

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death