BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 3560976 · Received January 8, 2014

    Report

    Report Number
    9616099-2014-00020
    Event Type
    Injury
    Date Received
    January 8, 2014
    Date of Event
    December 16, 2013
    Report Date
    December 18, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE SAPPHIRE REGISTRY APPROXIMATELY TWELVE DAYS POST CAROTID ARTERY STENTING (CAS) IN THE RIGHT PROXIMAL INTERNAL CAROTID ARTERY WITH A 9X30MM PRECISE STENT, AN 83 YEAR-OLD FEMALE PATIENT EXPERIENCED CLOUDY VISION THAT WAS DIAGNOSED AS EMBOLIC RETINAL ARTERY BRANCH OCCLUSION. THE PATIENT WAS ASYMPTOMATIC AT STUDY INCLUSION. MEDICAL HISTORY INCLUDED HYPERLIPIDEMIA, DIABETES MELLITUS, CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, CORONARY PERCUTANEOUS REVASCULARIZATION AND HYPERTENSION. NIH AND RANKIN SCORES WERE BOTH 0. CAS WAS PERFORMED ON AN 80% OCCLUDED LESION IN THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY OF 10MM IN LENGTH IN A 6.0MM VESSEL DIAMETER WITH MILD VESSEL TORTUOSITY. THE ARCH I LESION WAS ULCERATED, ECCENTRIC AND MILDLY CALCIFIED. A 6MM ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED PAST THE LESION AND PRE-DILATATION WAS PERFORMED. A 9X30MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. THERE WAS NO DOCUMENTED DISSECTION DURING PREDILATATION OR PRESENCE OR AIR BUBBLES DURING THE PROCEDURE. THE ANGIOGUARD WAS REMOVED AND THERE WAS NO DEBRIS FOUND IN THE BASKET. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE AND WAS DISCHARGED ON THE FOLLOWING DAY WITHOUT ANY ADVERSE EVENTS. NIH AND RANKIN SCORES WERE BOTH 0. 11 DAYS LATER THE PATIENT HAD SUDDEN ONSET OF CLOUDY VISION IN THE RIGHT EYE AND WAS REFERRED TO AN OPHTHALMOLOGIST WHO DIAGNOSED EMBOLIC RETINAL ARTERY BRANCH OCCLUSION. THE PATIENT HAD PARTIAL RECOVERY WITH MINOR RESIDUAL WHICH WERE VISION CHANGES (BLURRED/CLOUDY VISION IN RIGHT EYE, UNABLE TO READ AT A DISTANCE). THE EYE DOCTOR GAVE HER SOME EXERCISES TO PERFORM ON HER EYE FOR HER RIGHT EYE VISION CHANGES. THERE WAS SOME IMPROVEMENT IN THE FIELD DEFICIT AT 30 DAY FOLLOW UP HOWEVER THE PATIENT WAS STILL UNABLE TO READ AT A DISTANCE. AT THE 30 DAY FOLLOW-UP, THE NIH WAS REVISED FROM 1 TO 0. THE RANKIN SCORE WAS 2 BASED ON THE VISION CHANGE IN THE RIGHT EYE. THE PRODUCT REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. RETINAL ARTERY OCCLUSION IS A BLOCKAGE IN ONE OF THE SMALL ARTERIES THAT CARRY BLOOD TO THE RETINA. THE RETINA IS A LAYER OF TISSUE IN THE BACK OF THE EYE THAT IS ABLE TO SENSE LIGHT. RETINAL ARTERIES MAY BECOME BLOCKED BY A BLOOD CLOT OR FAT DEPOSITS THAT GET STUCK IN THE ARTERIES. THESE BLOCKAGES ARE MORE LIKELY IF THERE IS HARDENING OF THE ARTERIES ATHEROSCLEROSIS IN THE EYE. CLOTS MAY TRAVEL FROM OTHER PARTS OF THE BODY AND BLOCK AN ARTERY IN THE RETINA. THE MOST COMMON SOURCES OF CLOTS ARE THE HEART AND CAROTID ARTERY IN THE NECK. MOST BLOCKAGES OCCUR IN PEOPLE WITH CONDITIONS SUCH AS CAROTID ARTERY DISEASE, DIABETES, HEART RHYTHM PROBLEM, HEART VALVE PROBLEM, HIGH LEVELS OF FAT IN THE BLOOD (HYPERLIPIDEMIA), HIGH BLOOD PRESSURE, INTRAVENOUS DRUG ABUSE AND TEMPORAL ARTHRITIS. IF A BRANCH OF THE RETINAL ARTERY IS BLOCKED, PART OF THE RETINA WILL NOT RECEIVE ENOUGH BLOOD AND OXYGEN. IF THIS HAPPENS, YOU MAY LOSE PART OF YOUR VISION. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    ADJUDICATION MINUTES RECEIVED CLASSIFIED THE EVENT AS A CVA WHICH WAS PREVIOUSLY REPORTED AS RETINAL EDEMA BRANCH OCCLUSION. (B)(4). CENTRAL RETINAL ARTERY OCCLUSION, RIGHT EYE WITH SIGNIFICANT OCCLUSION OF THE INFERO-TEMPORAL BRANCH RETINAL ARTERY, CAUSING EDEMA AND VISION LOSS; RETINAL EDEMA SECONDARY TO ARTERY OCCLUSION; RETINAL ISCHEMIA, RIGHT EYE. THE SITE REPORTED THIS AS OTHER NEUROLOGICAL EVENT: EMBOLIC RETINAL ARTERY BRANCH OCCLUSION. AT 30 DAY FOLLOW-UP VISIT ON (B)(6) 2014 THERE WAS SOME IMPROVEMENT NOTED FOR THE VISION FIELD DEFICIT, BUT THE PATIENT WAS STILL UNABLE TO READ AT A DISTANCE. THE NIH STROKE SCALE SCORE WAS 0 AND THE RANKIN STROKE SCALE SCORE WAS 2 WITH A NOTE: VISION CHANGE, RIGHT EYE. ADDITIONAL CLARIFICATION REGARDING NIH STROKE SCALE SCORE OF 0 WITH A NOTE OF VISUAL DEFICITS WAS REQUESTED. THE SITE RESPONDED: ¿NIH STROKE SCALE SCORE FOR VISUAL FIELD IS CONFIRMED AS ¿0¿ AT 30 DAY FOLLOW UP. THERE WAS A NOTE TO FILE IN THE RESEARCH CHART CLARIFYING IF THIS WAS A ¿0¿ OR ¿1.¿¿ ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW OF THE CEC MINUTES, THE REPORTED EVENT REMAINS CENTRAL RETINAL ARTERY OCCLUSION RATHER THAN CVA. NO FURTHER INFORMATION IS AVAILABLE AND NO FURTHER REPORTS WILL BE FORTHCOMING. AN EXACT PATIENT CODE FOR THIS EVENT IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS: BIVALRUDIN WAS GIVEN DURING THE PROCEDURE. PRE AND POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. THE PRODUCT REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DIAGNOSIS OF THE EVENT WAS REVISED TO EMBOLIC RETINAL ARTERY BRANCH OCCLUSION PER THE OPHTHALMOLOGIST WHO SAW THE PATIENT. THE PATIENT HAD PARTIAL RECOVERY WITH MINOR RESIDUAL WHICH WERE VISION CHANGES (BLURRED/CLOUDY VISION IN RIGHT EYE, UNABLE TO READ AT A DISTANCE). THE EYE DOCTOR GAVE HER SOME EXERCISES TO PERFORM ON HER EYE FOR HER RIGHT EYE VISION CHANGES. THERE WAS SOME IMPROVEMENT IN THE FIELD DEFICIT AT 30 DAY FOLLOW UP HOWEVER, THE PATIENT WAS STILL UNABLE TO READ AT A DISTANCE. AT THE 30 DAY FOLLOW-UP, THE NIH WAS REVISED FROM 1 TO 0. THE RANKIN SCORE WAS 2 BASED ON THE VISION CHANGE IN THE RIGHT EYE.

    Description of Event or Problem · 1

    AS REPORTED BY THE SAPPHIRE REGISTRY APPROXIMATELY TWELVE DAYS POST CAROTID ARTERY STENTING (CAS) IN THE RIGHT PROXIMAL INTERNAL CAROTID ARTERY WITH A 9X30MM PRECISE STENT, A PATIENT EXPERIENCED CLOUDY VISION AND THE RECOVERY WAS UNKNOWN. A DIAGNOSIS WAS NOT GIVEN. THE PATIENT WAS ASYMPTOMATIC AT STUDY INCLUSION. NIH AND RANKIN SCORES WERE BOTH 0. CAS WAS PERFORMED ON AN 80% OCCLUDED LESION IN THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY OF 10MM IN LENGTH IN A 6.0MM VESSEL DIAMETER WITH MILD VESSEL TORTUOSITY. THE ARCH I LESION WAS ULCERATED, ECCENTRIC AND MILDLY CALCIFIED. A 6MM ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED PAST THE LESION AND PRE-DILATATION WAS PERFORMED. A 9X30MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. THERE WAS NO DOCUMENTED DISSECTION DURING PREDILATATION OR PRESENCE OR AIR BUBBLES DURING THE PROCEDURE. THE ANGIOGUARD WAS REMOVED AND THERE WAS NO DEBRIS FOUND IN THE BASKET. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE AND WAS DISCHARGED ON THE FOLLOWING DAY WITHOUT ANY ADVERSE EVENTS. NIH AND RANKIN SCORES WERE BOTH 0. ELEVEN DAYS LATER THE PATIENT HAD SUDDEN ONSET OF CLOUDY VISION IN THE RIGHT EYE AND WAS REFERRED TO AN OPHTHALMOLOGIST. THE PATIENT WILL BE SEEN AT THE 30 DAY FOLLOW UP. A DIAGNOSIS WAS NOT INDICATED. THE RECOVERY IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14383 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15925993

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| S 6MM ANGIOGUARD EMBOLIC PROTECTION DEVICE