BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    MDR report key: 7100664 · Received December 8, 2017

    Report

    Report Number
    3005687633-2017-00131
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    April 3, 2017
    Report Date
    February 8, 2018
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    LWR
    PMA / PMN Number
    P150011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOTIFIED TO THE MANUFACTURER THROUGH THE (B)(6) REGISTRY. THE SITE REPORTED THIS EVENT AS UNKNOWN FOR DEVICE RELATION. THE MANUFACTURER REQUESTED THE INTERNAL CLINICAL REVIEW OF THIS EVENT WHICH ASSESSED AS UNKNOWN FOR DEVICE RELATION. AS REPORTED IN THE PERCEVAL IFU, STROKE IS A KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CARDIAC VALVE REPLACEMENT WITH A BIOPROSTHESIS. AS REPORTED IN THE SCIENTIFIC LITERATURE "STROKE IS A DEVASTATING COMPLICATION THAT MAY OCCUR EARLY OR LATE AFTER OPERATION IN PATIENTS WITH PROSTHETIC HEART VALVES AND RESULT FROM EMBOLISM, INTRACRANIAL HEMORRHAGE, OR BOTH ALTHOUGH INTRACRANIAL HEMORRHAGE IS A RELATIVELY RARE EVENT EXCEPT IN ELDERLY ANTICOAGULATED PATIENTS, AN EMBOLIC STROKE MAY OCCUR IN VIRTUALLY ANY PATIENT AND WITH ANY TYPE OF VALVE PROSTHESIS. RISK FACTORS FOR STROKE IN THE GENERAL POPULATION INCLUDE ADVANCED AGE, ATRIAL FIBRILLATION, CORONARY ARTERY DISEASE, CONGESTIVE HEART FAILURE, MITRAL ANNULAR CALCIFICATION, HYPERTENSION, DIABETES, AND SMOKING. IN PATIENTS WITH PROSTHETIC HEART VALVES, THESE AND OTHER PATIENT-RELATED CHARACTERISTICS COULD INTERPLAY WITH THE DESIGN OF THE PROSTHESIS, THE SITE OF IMPLANTATION, AND THE ADEQUATENESS OF ANTICOAGULATION." RUEL, MARC, ET AL. "LATE INCIDENCE AND DETERMINANTS OF STROKE AFTER AORTIC AND MITRAL VALVE REPLACEMENT." THE ANNALS OF THORACIC SURGERY 78.1 (2004): 77-83. NOT EXPLANTED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION FROM THE SITE INDICATING THAT AT THE PATIENT'S FOLLOW-UPS, NO ADVERSE EVENTS HAD OCCURRED. BASED ON CLINICAL EVALUATION, IT WAS REPORTED THAT THE STROKE WAS BELIEVED TO BE NOT VALVE-RELATED. BASED ON THE INFORMATION RECEIVED, THERE IS NO KNOWN DEVICE PROBLEM.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED OF THIS EVENT FROM THE (B)(6) CLINICAL REGISTRY: A PERCEVAL SIZE 25MM WAS IMPLANTED ON (B)(6) 2012 VIA MINI THORACOTOMY. POST DILATATION BALLOONING WAS PERFORMED. ON (B)(6) 2017, THE PATIENT EXHIBITED A STROKE. THE SITE REPORTED AS UNKNOWN FOR DEVICE RELATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879838 PERCEVAL SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVES LWR SORIN GROUP ITALIA S.R.L. PVS25

    Patients

    Seq Age Sex Outcome Treatment
    1 Other