BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 3754541 · Received April 16, 2014

    Report

    Report Number
    9616099-2014-00272
    Event Type
    Injury
    Date Received
    April 16, 2014
    Date of Event
    January 15, 2014
    Report Date
    March 27, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S RUE IS FLACCID AND NO NOTED VOLITIONAL MOVEMENT AT ALL. OCCUPATIONAL/PHYSICAL THERAPY SAW THE PATIENT. PATIENT PARTICIPATED IN OCCUPATIONAL THERAPY WITH TREATMENT FOCUS ON SELF CARE SKILLS TRAINING, RUE FACILITATION, NEUROMUSCULAR RE-EDUCATION, AND LEFT HAND COORDINATION SKILLS TRAINING. THE PATIENT WAS OUT OF BED (OOB) WITH PHYSICAL THERAPY WHO CLEARED THE PATIENT FOR HOME WITH OUTPATIENT PHYSICAL THERAPY. PATIENT WAS TOLERATING REGULAR DIET AND WAS PLACED ON BOWEL REGIMEN, GI PROPHYLAXIS DURING THE HOSPITAL STAY. THE PATIENT WAS STARTED ON APPROPRIATE HOME MEDS DURING THE HOSPITAL DAY. THE PATIENT WAS DISCHARGED FIVE DAYS FOLLOWING ADMISSION IN ¿GOOD¿ CONDITION. A 30 DAY FOLLOW UP COULD NOT BE CONDUCTED AS THE PATIENT WAS UNABLE TO BE REACHED. THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION AS IT REMAINS IMPLANTED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. CONCOMITANT MEDICATIONS: HEPARIN WAS GIVEN DURING THE PROCEDURE. PRE AND POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL, LIPITOR, LISINOPRIL, NITROGLYCERINE, PROPAFENONE, VITAMIN D3, AND ATENOLOL. POST-PROCEDURE MEDICATIONS INCLUDED CEFAZOLIN, KEPPRA, PANTOPRAZOLE, SODIUM CHLORIDE, AND HYDROCODONE WITH ACETAMINOPHEN. CONCOMITANT DEVICES: ANGIOGUARD RX CATALOG NUMBER UNK, LOT NUMBER UNK.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED BY THE SAPPHIRE REGISTRY THE PATIENT HAD A STROKE (INTRACEREBRAL/SUBARACHNOID HEMORRHAGE) APPROXIMATELY 6 DAYS POST-INDEX PROCEDURE. THE PATIENT EXPERIENCED RIGHT HEMIPARESIS. THE EVENT WAS UNRELATED TO ANTICOAGULATION. THE DURATION OF THE NEUROLOGICAL DEFICIT WAS PERMANENT. THE EVENT WAS DEEMED UNRELATED TO THE INDEX PROCEDURE AND CORDIS PRODUCT. ONSET WAS SUDDEN AND RECOVERY UNKNOWN. PRE-PROCEDURE NIH STROKE SCALE SCORE WAS 0 AND RANKIN SCORE WAS 0. CAROTID ARTERY STENTING (CAS) WAS PERFORMED ON A 95% OCCLUDED LESION IN THE PROXIMAL LEFT INTERNAL CAROTID. THE ARCH II LESION HAD NO DOCUMENTED CALCIFICATION AND TORTUOSITY. THE TARGET LESION LENGTH AND VESSEL DIAMETER ARE UNKNOWN. A 7MM BASKET ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS DEPLOYED PAST THE LESION AND THE LESION WAS PRE-DILATED. A 7X30MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE RESIDUAL DIAMETER STENOSIS MEASURED 20%. THERE WAS NO DOCUMENTED PRESENCE OF AIR BUBBLES. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIOGRAPHY SUITE. THE PATIENT WAS DISCHARGED ON THE FOLLOWING DAY WITHOUT ANY ADVERSE EVENTS REPORTED. APPROXIMATELY 6 DAYS LATER, THE PATIENT WAS ADMITTED WITH INTRACEREBRAL HEMORRHAGE (ICH). THE PATIENT NOTICED THAT HIS RIGHT ARM BECAME ACUTELY WEAK AND STOPPED WORKING. CT HEAD REVEALED A 2.3X1.3CM LEFT PARIETAL INTRAPARENCHYMAL HEMORRHAGE (IPH). BLOOD PRESSURE THERE WAS 220/110, BUT HE WAS GCS 15 WITH DENSE RIGHT UPPER EXTREMITY (RUE) PARESIS. HE ENDORSES A ¿FUZZY¿ FEELING IN HIS HEAD, AND RIGHT UPPER EXTREMITY PARESIS (0/5 FROM DELTOID DOWN).THE PATIENT DENIES TRAUMATIC INJURY, HEADACHES, NAUSEA/VOMITING, LEVEL OF CONSCIOUSNESS, SEIZURES, VISION CHANGES, PARESTHESIAS, OTHER WEAKNESS, INCONTINENCE, OR PAIN. THE PATIENT IS COGNITIVELY INTACT AND FOLLOWS ALL INSTRUCTIONS. THE PATIENT STATED, ¿I AM GOOD ALL EXCEPT FOR MY RIGHT ARM. IT IS DEAD WITH THE MOVEMENT BUT I CAN FEEL EVERYTHING.¿ THE PATIENT¿S RUE IS FLACCID AND NO NOTED VOLITIONAL MOVEMENT AT ALL. OCCUPATIONAL/PHYSICAL THERAPY SAW THE PATIENT. PATIENT PARTICIPATED IN OCCUPATIONAL THERAPY WITH TREATMENT FOCUS ON SELF CARE SKILLS TRAINING, RUE FACILITATION, NEUROMUSCULAR RE-EDUCATION, AND LEFT HAND COORDINATION SKILLS TRAINING. THE PATIENT WAS OUT OF BED (OOB) WITH PHYSICAL THERAPY WHO CLEARED THE PATIENT FOR HOME WITH OUTPATIENT PHYSICAL THERAPY. PATIENT WAS TOLERATING REGULAR DIET AND WAS PLACED ON BOWEL REGIMEN, GI PROPHYLAXIS DURING THE HOSPITAL STAY. THE PATIENT WAS STARTED ON APPROPRIATE HOME MEDS DURING THE HOSPITAL DAY. THE PATIENT WAS DISCHARGED FIVE DAYS FOLLOWING ADMISSION IN ¿GOOD¿ CONDITION. A 30 DAY FOLLOW UP COULD NOT BE CONDUCTED AS THE PATIENT WAS UNABLE TO BE REACHED. THE (B)(6) MALE PATIENT HAS A MEDICAL HISTORY OF RIGHT ENDARTERECTOMY FOUR YEARS PRIOR, HYPERLIPIDEMIA, CARDIAC ARRHYTHMIA, HISTORY OF SMOKING (>5 PACKS OF CIGARETTES),CORONARY ARTERY DISEASE, CORONARY PERCUTANEOUS REVASCULARIZATION, AND HYPERTENSION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15967239 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. INTRACEREBRAL HEMORRHAGE OCCURS WHEN A DISEASED BLOOD VESSEL WITHIN THE BRAIN BURSTS, ALLOWING BLOOD TO LEAK INSIDE THE BRAIN. THE SUDDEN INCREASE IN PRESSURE WITHIN THE BRAIN CAN CAUSE DAMAGE TO THE BRAIN CELLS SURROUNDING THE BLOOD. IF THE AMOUNT OF BLOOD INCREASES RAPIDLY, THE SUDDEN BUILDUP IN PRESSURE CAN LEAD TO UNCONSCIOUSNESS OR DEATH. INTRACEREBRAL HEMORRHAGE USUALLY OCCURS IN SELECTED PARTS OF THE BRAIN, INCLUDING THE BASAL GANGLIA, CEREBELLUM, BRAINSTEM, OR CORTEX. THE MOST COMMON CAUSE OF INTRACEREBRAL HEMORRHAGE IS HIGH BLOOD PRESSURE (HYPERTENSION). AFTER REVASCULARIZATION THAT ALLEVIATES A HIGH-GRADE SYMPTOMATIC STENOTIC LESION, CEREBRAL HYPERPERFUSION MAY OCCUR AS A RESULT OF A SUDDEN, RAPID INCREASE IN CEREBRAL BLOOD FLOW EXCESS OF THAT REQUIRED TO MEET METABOLIC DEMANDS. ANTICOAGULATION IS A KNOWN RISK FACTOR FOR BRAIN HEMORRHAGE IN PATIENTS WITH PRE-EXISTING DISEASE. LESS COMMON CAUSES OF INTRACEREBRAL HEMORRHAGE INCLUDE TRAUMA, INFECTIONS, TUMORS, BLOOD CLOTTING DEFICIENCIES, AND ABNORMALITIES IN BLOOD VESSELS (SUCH AS ARTERIOVENOUS MALFORMATIONS). TYPICALLY, INTRACEREBRAL HEMORRHAGE DEVELOPS ON THE THIRD TO FIFTH POST PROCEDURE DAY, THOUGH THERE HAVE BEEN CASES OBSERVED IMMEDIATELY AFTER SURGERY, AS WELL AS CASES DEVELOPED 3 WEEKS AFTER REVASCULARIZATION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS AND/OR VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) THE PATIENT HAD A STROKE (INTRACEREBRAL/SUBARACHNOID HEMORRHAGE) APPROXIMATELY 6 DAYS POST-INDEX PROCEDURE. THE PATIENT EXPERIENCED RIGHT HEMIPARESIS. THE EVENT WAS UNRELATED TO ANTICOAGULATION. THE DURATION OF THE NEUROLOGICAL DEFICIT WAS PERMANENT. THE EVENT WAS DEEMED UNRELATED TO THE INDEX PROCEDURE AND CORDIS PRODUCT. ONSET WAS SUDDEN AND RECOVERY UNKNOWN. PRE-PROCEDURE NIH STROKE SCALE SCORE WAS 0 AND RANKIN SCORE WAS 0. CAROTID ARTERY STENTING (CAS) WAS PERFORMED ON A 95% OCCLUDED LESION IN THE PROXIMAL LEFT INTERNAL CAROTID. THE ARCH II LESION HAD NO DOCUMENTED CALCIFICATION AND TORTUOSITY. THE TARGET LESION LENGTH AND VESSEL DIAMETER ARE UNKNOWN. A 7MM BASKET ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS DEPLOYED PAST THE LESION AND THE LESION WAS PRE-DILATED. A 7X30MM PRECISE PRO RX STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE RESIDUAL DIAMETER STENOSIS MEASURED 20%. THERE WAS NO DOCUMENTED PRESENCE OF AIR BUBBLES. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIOGRAPHY SUITE. THE PATIENT WAS DISCHARGED ON THE FOLLOWING DAY WITHOUT ANY ADVERSE EVENTS REPORTED. APPROXIMATELY 6 DAYS LATER, THE PATIENT WAS ADMITTED WITH INTRACEREBRAL HEMORRHAGE (ICH). THE PATIENT NOTICED THAT HIS RIGHT ARM BECAME ACUTELY WEAK AND STOPPED WORKING. CT HEAD REVEALED A 2.3X1.3CM LEFT PARIETAL INTRAPARENCHYMAL HEMORRHAGE (IPH). BLOOD PRESSURE THERE WAS 220/110, BUT HE WAS GCS 15 WITH DENSE RIGHT UPPER EXTREMITY (RUE) PARESIS. HE ENDORSES A ¿FUZZY¿ FEELING IN HIS HEAD, AND RIGHT UPPER EXTREMITY PARESIS (0/5 FROM DELTOID DOWN).THE PATIENT DENIES TRAUMATIC INJURY, HEADACHES, NAUSEA/VOMITING, LEVEL OF CONSCIOUSNESS, SEIZURES, VISION CHANGES, PARESTHESIAS, OTHER WEAKNESS, INCONTINENCE, OR PAIN. THE PATIENT IS COGNITIVELY INTACT AND FOLLOWS ALL INSTRUCTIONS. THE PATIENT STATED, ¿I AM GOOD ALL EXCEPT FOR MY RIGHT ARM. IT IS DEAD WITH THE MOVEMENT BUT I CAN FEEL EVERYTHING.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232661 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15967239

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| L| R| S