BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2985306 · Received March 1, 2013

    Report

    Report Number
    9616099-2013-00111
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    April 27, 2009
    Report Date
    February 8, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE EVENT DATE INDICATED IS ATTRIBUTED TO THE DATE OF THE PUBLICATION OF THE ATTACHED JOURNAL ARTICLE: PHATOUROS ET AL CEREBRAL HYPERPERFUSION SYNDROME POST-CAROTID ARTERY STENTING; JOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY; 53 (2009) 81-86. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    PHATOUROS ET AL CEREBRAL HYPERPERFUSION SYNDROME POST-CAROTID ARTERY STENTING; JOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY; 53 (2009) 81-86; REPORT A CASE WHERE A PATIENT HAD CAS AND 24 HOURS AFTER CESSASATION OF HEPARIN, HE DEVELOPED FRONTAL HEADACHES AND SLIGHT INCREASE IN THE WEAKNESS OF HIS LEFT ARM AND 6 DAYS AFTER HE DEVELOPED DROWSINESS. A CT SCAN WAS OBTAINED, WHICH SHOWED MULTIPLE SMALL HAEMORRHAGIC FOCI WITHIN THE RIGHT MCA TERRITORY, INCLUDING THE BASAL GANGLIA. THERE WAS ALSO SOME SUBARACHNOID AND INTRAVENTRICULAR BLOOD. THE MRI SHOWED ADDITIONALLY BLOOD IN THE CORPUS CALLOSUM AND OCCIPITAL LOBES. THIS WAS TREATED CONSERVATIVELY WITH TEMPORARY CESSATION OF THE ANTIPLATELET AGENTS AND STRICT MONITORING OF THE BLOOD PRESSURE. THREE MONTHS LATER PATIENT WAS INDEPENDENT IN TOILETING, GROOMING AND FEEDING AND WAS AMBULANT WITH A ZIMMER FRAME WITH VERY MILD RESIDUAL LEFT WEAKNESS (4+/5). BEFORE ADMISSION HE WAS WALKING WITH A STICK WITH NORMAL POWER. PRIOR TO THE CAROTID PROCEDURE, THAT PATIENT HAD A RIGHT RETINAL STROKE AND EPISODES OF WEAKNESS AFFECTING BOTH SIDES FOR A FEW MONTHS BEFORE STENTING. AN MRI SHOWED RECENT PATCHY INFARCT INVOLVING THE RIGHT FRONTAL LOBE AND CORONA RADIATA WHITE MATTER IN THE WATERSHED DISTRIBUTION AND PATIENT HAD 98+% STENOSIS ON THE RIGHT ICA WITH A 50% STENOSIS ON THE LEFT ICA. HE HAD FROM HYPERTENSION AND ATRIAL FIBRILLATION AND WAS A HEAVY SMOKER. THE CAROTID ANGIOGRAM SHOWED A PREOCCLUSIVE RIGHT ICA AND THE PATIENT ALSO HAD A MODERATELY LARGE RIGHT POSTERIOR COMMUNICATING ARTERY. PRE-STENT BALLOON ANGIOPLASTY WAS CARRIED OUT THEN AN EZ FILTER WIRE WAS INSERTED PAST THE STENOSIS FOLLOWED BY PLACEMENT OF A 7 MM - 30 MM PRECISE STENT. THERE WAS A GOOD RESULT WITH RESTORATION OF THE LUMEN AND NO IMMEDIATE COMPLICATIONS. HIS POSTOPERATIVE BLOOD PRESSURE WAS 140-150 MMHG. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. CEREBRAL HYPERPERFUSION SYNDROME (CHS) IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CAROTID STENTS. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    PHATOUROS ET AL CEREBRAL HYPERPERFUSION SYNDROME POST-CAROTID ARTERY STENTING; JOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY; 53 (2009) 81-86; REPORT A CASE WHERE A PATIENT HAD CAS AND 24 HOURS AFTER CESSASATION OF HEPARIN, HE DEVELOPED FRONTAL HEADACHES AND SLIGHT INCREASE IN THE WEAKNESS OF HIS LEFT ARM AND 6 DAYS AFTER HE DEVELOPED DROWSINESS. A CT SCAN WAS OBTAINED, WHICH SHOWED MULTIPLE SMALL HAEMORRHAGIC FOCI WITHIN THE RIGHT MCA TERRITORY, INCLUDING THE BASAL GANGLIA. THERE WAS ALSO SOME SUBARACHNOID AND INTRAVENTRICULAR BLOOD. THE MRI SHOWED ADDITIONALLY BLOOD IN THE CORPUS CALLOSUM AND OCCIPITAL LOBES. THIS WAS TREATED CONSERVATIVELY WITH TEMPORARY CESSATION OF THE ANTIPLATELET AGENTS AND STRICT MONITORING OF THE BLOOD PRESSURE. THREE MONTHS LATER PATIENT WAS INDEPENDENT IN TOILETING, GROOMING AND FEEDING AND WAS AMBULANT WITH A ZIMMER FRAME WITH VERY MILD RESIDUAL LEFT WEAKNESS (4+/5). BEFORE ADMISSION HE WAS WALKING WITH A STICK WITH NORMAL POWER. PRIOR TO THE CAROTID PROCEDURE, THAT PATIENT HAD A RIGHT RETINAL STROKE AND EPISODES OF WEAKNESS AFFECTING BOTH SIDES FOR A FEW MONTHS BEFORE STENTING. AN MRI SHOWED RECENT PATCHY INFARCT INVOLVING THE RIGHT FRONTAL LOBE AND CORONA RADIATA WHITE MATTER IN THE WATERSHED DISTRIBUTION AND PATIENT HAD 98+% STENOSIS ON THE RIGHT ICA WITH A 50% STENOSIS ON THE LEFT ICA. HE HAD FROM HYPERTENSION AND ATRIAL FIBRILLATION AND WAS A HEAVY SMOKER. THE CAROTID ANGIOGRAM SHOWED A PREOCCLUSIVE RIGHT ICA AND THE PATIENT ALSO HAD A MODERATELY LARGE RIGHT POSTERIOR COMMUNICATING ARTERY. PRE-STENT BALLOON ANGIOPLASTY WAS CARRIED OUT THEN AN EZ FILTER WIRE WAS INSERTED PAST THE STENOSIS FOLLOWED BY PLACEMENT OF A 7 MM _ 30 MM PRECISE STENT. THERE WAS A GOOD RESULT WITH RESTORATION OF THE LUMEN AND NO IMMEDIATE COMPLICATIONS. HIS POSTOPERATIVE BLOOD PRESSURE WAS 140-150 MMHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88931 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS NIM CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR