BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPEL SINUS IMPLANT

    MDR report key: 5490510 · Received March 9, 2016

    Report

    Report Number
    3010101669-2016-00003
    Event Type
    Malfunction
    Date Received
    March 9, 2016
    Report Date
    February 10, 2016
    Manufacturer
    INTERSECT ENT
    Product Code
    OWO
    PMA / PMN Number
    P100044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VOLUNTARY EVENT REPORT (MW 5060385) WHICH CONTAINED ADDITIONAL INFORMATION WAS RECEIVED ON 3/24/2016. ADDITIONAL NARRATIVE: THE INFORMATION PROVIDED IN THE INITIAL REPORT INDICATED THAT THE PATIENT VISITED ER. CLINICAL QUALITY, SAFETY & RISK SPECIALIST FROM THE HOSPITAL CONFIRMED THE PATIENT DID NOT MENTION AN ER VISIT WHEN REPORTING THE EVENT TO THEM. ADDITIONALLY, THE HOSPITAL HAD NO RECORD OF THE PATIENT RECEIVING TREATMENT IN THEIR ER. BASED ON THE LHR REVIEW, THE PRODUCT MET ALL SPECIFICATIONS. A POTENTIAL ROOT CAUSE RELATED TO MANUFACTURING / PROCESS CONTROL COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN STATED THE IMPLANT WAS PLACED CORRECTLY, HOWEVER THE PATIENT'S ANATOMY MAY HAVE CONTRIBUTED TO THE MIGRATION. IN AN ABUNDANCE OF CAUTION, INTERSECT ENT IS REPORTING THIS EVENT AS A MALFUNCTION BASED ON THE INFORMATION RECEIVED AND THE REMOTE POSSIBILITY OF A SERIOUS INJURY SHOULD A SIMILAR EVENT OCCUR. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT REVISION ENDOSCOPIC SINUS SURGERY (ESS) (B)(6) 2015. SINUS IMPLANTS WERE PLACED BILATERALLY, IN PREVIOUSLY MODIFIED ANATOMY, IN THE ETHMOID SINUSES WITHOUT INCIDENT. APPROXIMATELY ONE WEEK POST-SURGERY WHILE THE PATIENT WAS DRIVING, THE IMPLANT ON THE RIGHT SIDE HAD MIGRATED TO THE PATIENT'S THROAT AREA; THE LEFT SIDE IMPLANT REMAINED IN PLACE. THE PATIENT REPORTED TO THE HOSPITAL THAT HE PULLED OFF THE FREEWAY AND REMOVED THE OBJECT FROM HIS THROAT MANUALLY AND THEN PROCEEDED TO DRIVE ON TO THEIR POST-OPERATIVE APPOINTMENT WITH THE PHYSICIAN. PATIENT IS FINE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT REVISION ENDOSCOPIC SINUS SURGERY (ESS) IN (B)(6) 2016. SINUS IMPLANTS WERE PLACED BILATERALLY, IN PREVIOUSLY MODIFIED ANATOMY, IN THE ETHMOID SINUSES WITHOUT INCIDENT. APPROXIMATELY ONE WEEK POST-SURGERY THE IMPLANT ON THE RIGHT SIDE HAD MIGRATED TO THE PATIENT'S THROAT AREA; THE LEFT SIDE IMPLANT REMAINED IN PLACE. THE PATIENT FELT SOMETHING IN THEIR THROAT (DESCRIBED AS A CHOKING SENSATION) AND CONCERNED ABOUT A POSSIBLE OBSTRUCTION OF THE AIRWAY WENT TO THE ER. THE REPORTING PHYSICIAN STATED THAT THE PATIENT COUGHED OUT THE IMPLANT PRIOR TO RECEIVING INTERVENTION WHILE IN THE ER; PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144957 PROPEL SINUS IMPLANT DRUG ELUTING SINUS STENT OWO INTERSECT ENT 70011 50828001

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR