BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE SDS SELF EXPANDING

    MDR report key: 4012881 · Received August 15, 2014

    Report

    Report Number
    9616099-2014-00532
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    September 23, 2013
    Report Date
    July 30, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K012993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPEAT CONVENTIONAL ANGIOGRAM WAS PERFORMED IN PLACE OF A CT OR CT ANGIOGRAPHY OF THE NECK IN THE EVENT THAT AN INTERVENTION WOULD BE REQUIRED. THE REPEAT ARTERIOGRAM REVEALED CONTRAST EXTRAVASATION FROM THE DISTAL LEFT EXTERNAL CAROTID ARTERY (ECA). A MICROCATHETER WAS ADVANCED INTO THE SUPERFICIAL TEMPORAL ARTERY, DISTAL TO THE ECA PERFORATION SITE, AND THE SUPERFICIAL TEMPORAL ARTERY AND DISTAL ECA WERE RETROGRADE EMBOLIZED DOWN TO THE PROXIMAL ECA WITH COILS. THE PATIENT WAS RETURNED TO THE ICU AND EXTUBATED THE FOLLOWING MORNING. HER FACIAL AND NECK SWELLING IMPROVED SIGNIFICANTLY BY THE NEXT EVENING, AND THE PATIENT WAS DISCHARGED HOME ON POST PROCEDURE DAY 2. THE ARTICLE REPORTED THE EVENT AS AN EXPANDING CERVICAL HEMATOMA DUE TO A PERFORATION OF THE ECA TRUNK. THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, IT IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. CONCOMITANT MEDICATIONS: HEPARIN WAS GIVEN DURING THE PROCEDURE. PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. CONCOMITANT DEVICES: SPIDERFX DISTAL PROTECTION DEVICE (COVIDIEN, IRVINE, CALIFORNIA, USA). THE CATALOG CODE PROVIDED (NXXXSB), REPRESENTS AN UNKNOWN PRECISE STENT. THE CATALOG AND LOT NUMBERS FOR THE ACTUAL PRODUCT USED IN THE PROCEDURE ARE UNKNOWN. THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: GRANDHI ET AL (2013). FACIAL AND NECK HEMATOMA AFTER CAROTID ARTERY STENTING: AN UNCOMMON MISADVENTURE IN ENDVASCULAR CAROTID REVASCULARIZATION. J NEUROINTERVENTIONAL SURGERY, 1-3.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY GRANDHI ET AL FACIAL AND NECK HEMATOMA AFTER CAROTID ARTERY STENTING: AN UNCOMMON MISADVENTURE IN ENDOVASCULAR CAROTID REVASCULARIZATION, J NEUROINTERVENTIONAL SURGERY (2013) 1-3; THE PATIENT UNDERWENT CAROTID ARTERY STENTING (CAS) WITH A 6X20MM PRECISE STENT FOR A SYMPTOMATIC 90% LEFT INTERNAL CAROTID ARTERY STENOSIS AND DEVELOPED AN EXPANDING CERVICAL HEMATOMA AFTER THE PROCEDURE WITH IMMINENT RESPIRATORY COMPROMISE. AFTER INTUBATION, AN ARTERIOGRAM REVEALED PERFORATION OF THE EXTERNAL CAROTID ARTERY TRUNK, PROXIMAL TO THE ORIGIN OF THE INTERNAL MAXILLARY ARTERY. THE ARTERY WAS SUBSEQUENTLY EMBOLIZED AND THE HEMATOMA RESOLVED WITHOUT FURTHER INTERVENTION. A WOMAN WITH A PAST MEDICAL HISTORY SIGNIFICANT FOR MYOCARDIAL INFARCTION, RIGHT CAROTID ENDARTERECTOMY, DYSLIPIDEMIA, AND CIGARETTE SMOKING PRESENTED AFTER A TRANSIENT ISCHEMIC ATTACK CHARACTERIZED BY TRANSIENT APHASIA AND RIGHT HEMIPARESIS. ON INITIAL EVALUATION, SHE WAS NEUROLOGICALLY INTACT WITH AN UNREMARKABLE NON-CONTRASTED CT HEAD AND MRI. CT ANGIOGRAPHY OF HER HEAD AND NECK DEMONSTRATED PROXIMAL LEFT INTERNAL CAROTID ARTERY (ICA) STENOSIS OF GREATER THAN 70%, WITH AN ASSOCIATED TANDEM LESION IN THE LEFT CAVERNOUS ICA, AND A PROXIMAL RIGHT ICA STENOSIS OF 80%. THE PATIENT UNDERWENT A CATHETER BASED ARTERIOGRAM, WHICH REVEALED 90% STENOSIS OF THE PROXIMAL LEFT ICA. CAROTID ARTERY STENOSIS (CAS) WAS PERFORMED WITH A 6×20 MM PRECISE STENT AND A 5.0 MM NON-CORDIS DISTAL PROTECTION DEVICE. NO COMPLICATIONS WERE NOTED. SHORTLY AFTER HER ARRIVAL TO THE INTENSIVE CARE UNIT, THE PATIENT COMPLAINED OF LEFT JAW, NECK, AND UPPER CHEST PAIN. A CARDIAC ETIOLOGY OF HER COMPLAINTS WAS IMMEDIATELY INVESTIGATED AND RULED OUT. OVER THE NEXT 6 HOURS, INCREASING LEFT FACIAL AND LATERAL NECK SWELLING WERE OBSERVED. DUE TO CONCERN FOR RESPIRATORY COMPROMISE, SHE WAS INTUBATED AND EMERGENTLY TAKEN FOR A REPEAT ANGIOGRAM. A REPEAT CONVENTIONAL ANGIOGRAM WAS PERFORMED IN PLACE OF A CT OR CT ANGIOGRAPHY OF THE NECK IN THE EVENT THAT AN INTERVENTION WOULD BE REQUIRED. THE REPEAT ARTERIOGRAM REVEALED CONTRAST EXTRAVASATION FROM THE DISTAL LEFT EXTERNAL CAROTID ARTERY (ECA). A MICROCATHETER WAS ADVANCED INTO THE SUPERFICIAL TEMPORAL ARTERY, DISTAL TO THE ECA PERFORATION SITE, AND THE SUPERFICIAL TEMPORAL ARTERY AND DISTAL ECA WERE RETROGRADE EMBOLIZED DOWN TO THE PROXIMAL ECA WITH COILS. THE PATIENT WAS RETURNED TO THE ICU AND EXTUBATED THE FOLLOWING MORNING. HER FACIAL AND NECK SWELLING IMPROVED SIGNIFICANTLY BY THE NEXT EVENING, AND THE PATIENT WAS DISCHARGED HOME ON POST PROCEDURE DAY 2. THE ARTICLE REPORTED THE EVENT AS AN EXPANDING CERVICAL HEMATOMA DUE TO A PERFORATION OF THE ECA TRUNK. THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, IT IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE DOCUMENTED AS THE LOT NUMBER WAS NOT PROVIDED. CAROTID ARTERY PERFORATION/RUPTURE IS A KNOWN POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE CAN DISRUPT THE VESSEL PLAQUE AND INTIMA CAUSING DAMAGE TO THE ARTERY. THE HEMATOMA AND SWELLING THAT OCCURRED DUE TO THE PERFORATION IS AN EXPECTED RESULT OF A PERFORATED ARTERY. THE REPORTED CAROTID ARTERY PERFORATION/RUPTURE IS MOST LIKELY RELATED TO THE PATIENT¿S VESSEL CHARACTERISTICS (SUCH CALCIFICATION) AND/OR OPERATOR TECHNIQUE. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. HOWEVER, THERE IS NO INDICATION OF MANUFACTURING OR DESIGN ISSUES THAT MAY HAVE CONTRIBUTED TO THE EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY GRANDHI ET AL FACIAL AND NECK HEMATOMA AFTER CAROTID ARTERY STENTING: AN UNCOMMON MISADVENTURE IN ENDVASCULAR CAROTID REVASCULARIZATION, J NEUROINTERVENTIONAL SURGERY (2013) 1-3; THE PATIENT UNDERWENT CAROTID ARTERY STENTING (CAS) WITH A 6X20MM PRECISE STENT FOR A SYMPTOMATIC 90% LEFT INTERNAL CAROTID ARTERY STENOSIS AND DEVELOPED AN EXPANDING CERVICAL HEMATOMA AFTER THE PROCEDURE WITH IMMINENT RESPIRATORY COMPROMISE. AFTER INTUBATION, AN ARTERIOGRAM REVEALED PERFORATION OF THE EXTERNAL CAROTID ARTERY TRUNK, PROXIMAL TO THE ORIGIN OF THE INTERNAL MAXILLARY ARTERY. THE ARTERY WAS SUBSEQUENTLY EMBOLIZED AND THE HEMATOMA RESOLVED WITHOUT FURTHER INTERVENTION. A WOMAN WITH A PAST MEDICAL HISTORY SIGNIFICANT FOR MYOCARDIAL INFARCTION, RIGHT CAROTID ENDARTERECTOMY, DYSLIPIDEMIA, AND CIGARETTE SMOKING PRESENTED AFTER A TRANSIENT ISCHEMIC ATTACK CHARACTERIZED BY TRANSIENT APHASIA AND RIGHT HEMIPARESIS. ON INITIAL EVALUATION, SHE WAS NEUROLOGICALLY INTACT WITH AN UNREMARKABLE NON-CONTRASTED CT HEAD AND MRI. CT ANGIOGRAPHY OF HER HEAD AND NECK DEMONSTRATED PROXIMAL LEFT INTERNAL CAROTID ARTERY (ICA) STENOSIS OF GREATER THAN 70%, WITH AN ASSOCIATED TANDEM LESION IN THE LEFT CAVERNOUS ICA, AND A PROXIMAL RIGHT ICA STENOSIS OF 80%. THE PATIENT UNDERWENT A CATHETER BASED ARTERIOGRAM, WHICH REVEALED 90% STENOSIS OF THE PROXIMAL LEFT ICA. CAROTID ARTERY STENOSIS (CAS) WAS PERFORMED WITH A 6×20 MM PRECISE STENT AND A 5.0 MM NON-CORDIS DISTAL PROTECTION DEVICE. NO COMPLICATIONS WERE NOTED. SHORTLY AFTER HER ARRIVAL TO THE INTENSIVE CARE UNIT, THE PATIENT COMPLAINED OF LEFT JAW, NECK, AND UPPER CHEST PAIN. A CARDIAC ETIOLOGY OF HER COMPLAINTS WAS IMMEDIATELY INVESTIGATED AND RULED OUT. OVER THE NEXT 6 HOURS, INCREASING LEFT FACIAL AND LATERAL NECK SWELLING WERE OBSERVED. DUE TO CONCERN FOR RESPIRATORY COMPROMISE, SHE WAS INTUBATED AND EMERGENTLY TAKEN FOR A REPEAT ANGIOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489545 PRECISE SDS SELF EXPANDING SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R