BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 3012502 · Received March 20, 2013

    Report

    Report Number
    9616099-2013-00152
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    June 13, 2011
    Report Date
    August 11, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT FURTHER NOTED POWER 0/5 IN THE LEFT UPPER EXTREMITY, 5/5 IN LEFT LOWER EXTREMITY, 3/5 IN THE RIGHT UPPER EXTREMITY, AND 5/5 IN THE RIGHT LOWER EXTREMITY. DEEP TENDON REFLEXES WERE EQUIVOCAL ON BOTH SIDES. SHE FELT THAT SHE RECOVERED BUT STILL FELT NUMBNESS ON HER ARM. THE PATIENT HAD SIMILAR SYMPTOMS FROM THE PREVIOUS STROKE BUT FELT THE SYMPTOMS WERE NEW. THE PATIENT WAS DISCHARGED 3 DAYS LATER. THE PATIENT WAS FEELING BETTER EXCEPT THAT HER RIGHT SIDE WAS 4.5/5 IN STRENGTH. THE PATIENT WAS DISCHARGED HOME WITH OUTPATIENT REHABILITATION. PER THE INITIAL REPORT FROM STUDY, THE SYMPTOMS WERE RIGHT SIDED HEMIPARESIS AND HEMINEGLECT WITH REFLEX CHANGES. THE EVENT LASTED LESS THAN 24 HOURS AND RESOLVED COMPLETELY, WITH FULL RECOVERY. CAT SCAN AT THE TIME OF THE EVENT SHOWED A PATENT PRECISE STENT IN L5. CONCOMITANT MEDICATIONS CONTINUED: HEPARIN WAS GIVEN DURING THE PROCEDURE. PRE AND POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. CONCOMITANT DEVICES CONTINUED: ANGIOGUARD RX CATALOG NUMBER 601814REC, LOT NUMBER 7021503 ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE (B)(6) STUDY INDICATED THAT 10 MONTHS AFTER THE INDEX PROCEDURE A (B)(6) FEMALE PATIENT WITH MEDICAL HISTORY INCLUDING PREVIOUS STROKE, HODGKIN'S DISEASE, HYPERLIPIDEMIA AND SMOKING (>5PACKS OF CIGARETTES); HAD AN ISCHEMIC STROKE THAT WAS ADJUDICATED AS A CVA, WITH RESIDUALS REQUIRING REHABILITATION. NIH STROKE SCALE SCORE WAS 2 AS BASELINE AND THE RANKIN SCORE WAS 1. THE PATIENT WAS ALSO SYMPTOMATIC. DURING STUDY ADMISSION CAS WAS PERFORMED ON A 99% OCCLUDED LESION IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY OF 20MM IN LENGTH IN A 5.0MM VESSEL DIAMETER WITH MODERATE VESSEL TORTUOSITY. THE ARCH II LESION WAS MODERATELY CALCIFIED, ECCENTRIC AND ULCERATED. A 6MM EXTRA SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED PAST THE LESION WHICH WAS THEN PRE-DILATED FOLLOWED BY DEPLOYMENT OF AN 8X30MM PRECISE PRO RX STENT. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. THE ANGIOGUARD WAS SUCCESSFULLY REMOVED AND THERE WAS NO DEBRIS FOUND IN THE BASKET. THERE WAS NO DOCUMENTED DISSECTION. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE. THE PATIENT WAS DISCHARGED ON THE FOLLOWING DAY. RANKIN AND NIH STROKE SCALE SCORES WERE UNCHANGED. AT THE 30 DAY FOLLOW-UP NIH STROKE SCALE SCORE WAS 2 AND THE RANKIN WAS 0. THERE WERE NO REPORTED ADVERSE EVENTS. NINE MONTHS LATER THE PATIENT PRESENTED WITH COMPLAINTS OF A TINGLING SENSATION, NUMBNESS AND WEAKNESS IN THE RIGHT EXTREMITY WHILE WORKING. ON THE PREVIOUS DAY SHE ALSO HAD SOME MILD HEADACHE AND NUMBNESS TO THE RIGHT SIDE OF HER FACE AND ARMS. NEXT DAY SHE ALSO HAD ABRUPT WEAKNESS OF HER RIGHT ARM AND LEG THAT LASTED 20-30 MINUTES, SHE ALSO HAD A BRIEF EPISODE OF CONFUSION/LOSS OF CONSCIOUSNESS ASSOCIATED WITH DIZZINESS. ADMISSION NOTE INDICATED NOTED HISTORY OF PREVIOUS STROKE A PRIOR TO STENTING WITH RIGHT SIDED WEAKNESS THAT BE NOTED TO HAVE RESOLVED. PATIENT NOTED PREVIOUS STROKE HAD SIMILAR SYMPTOMS. NEUROLOGICAL REPORT NOTED THE PATIENT WAS ALERT, FULLY ORIENTED AND AWAKE WITH CRANIAL NERVES INTACT. THE REPORT FURTHER NOTED POWER 0/5 IN THE LEFT UPPER EXTREMITY, 5/5 IN LEFT LOWER EXTREMITY, 3/5 IN THE RIGHT UPPER EXTREMITY, AND 5/5 IN THE RIGHT LOWER EXTREMITY. DEEP TENDON REFLEXES WERE EQUIVOCAL ON BOTH SIDES. SHE FELT THAT SHE RECOVERED BUT STILL FELT NUMBNESS ON HER ARM. THE PATIENT HAD SIMILAR SYMPTOMS FROM THE PREVIOUS STROKE BUT FELT THE SYMPTOMS WERE NEW. THE PATIENT WAS DISCHARGED 3 DAYS LATER. THE PATIENT WAS FEELING BETTER EXCEPT THAT HER RIGHT SIDE WAS 4.5/5 IN STRENGTH. THE PATIENT WAS DISCHARGED HOME WITH OUTPATIENT REHABILITATION. PER THE INITIAL REPORT FROM STUDY, THE SYMPTOMS WERE RIGHT SIDED HEMIPARESIS AND HEMINEGLECT WITH REFLEX CHANGES. THE EVENT LASTED LESS THAN 24 HOURS AND RESOLVED COMPLETELY, WITH FULL RECOVERY. CAT SCAN AT THE TIME OF THE EVENT SHOWED A PATENT PRECISE STENT IN L5. 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. CEREBROVASCULAR ACCIDENT IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY AND IS LISTED IN THE IFU AS SUCH. IT CAN BE DEFINED AS A CEREBROVASCULAR DISORDER CAUSED BY DEPRIVATION OF BLOOD FLOW TO AN AREA OF THE BRAIN, GENERALLY AS A RESULT OF THROMBOSIS, EMBOLISM, OR REDUCED BLOOD PRESSURE. THE ACT OF STENT EXPANSION OR POST-DILATATION, TO OPTIMALLY OPPOSE A CAROTID STENT TO THE VESSEL WALL, TEMPORARILY OBSTRUCTS BLOOD FLOW TO THE CEREBRAL ARTERIES (ISCHEMIC PROCESS). THE PHYSICAL MANIPULATION OF THE CAROTID ARTERIES PRODUCES THE RISK OF DISLODGEMENT OF DEBRIS THAT MAY TRAVEL UPSTREAM TO THE CEREBRAL ARTERIES POTENTIALLY DISRUPTING PERFUSION. THIS ACT, INHERENT TO THE PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A BLOOD VESSEL THAT IS NOT BLOCKED, BUT IS EXTREMELY NARROWED, CAN ALSO CAUSE AN ISCHEMIC STROKE. THE BLOCKED OR NARROWED ARTERIES DEPRIVE BRAIN CELLS OF OXYGEN AND NUTRIENTS, LEADING TO NERVE CELL DEATH; 80% OF ALL STROKES ARE ISCHEMIC. DURING ISCHEMIC STROKE, DIMINISHED BLOOD FLOW INITIATES A SERIES OF EVENTS (CALLED ISCHEMIC CASCADE) THAT MAY RESULT IN ADDITIONAL, DELAYED DAMAGE TO BRAIN CELLS. EARLY MEDICAL INTERVENTION CAN HALT THIS PROCESS AND REDUCE THE RISK FOR IRREVERSIBLE COMPLICATIONS. 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.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT 10 MONTHS AFTER THE INDEX PROCEDURE A PATIENT HAD AN ISCHEMIC STROKE THAT WAS ADJUDICATED AS A CVA, WITH RESIDUALS REQUIRING REHABILITATION. NIH STROKE SCALE SCORE WAS 2 AS BASELINE AND THE RANKIN SCORE WAS 1. THE PATIENT WAS ALSO SYMPTOMATIC. DURING STUDY ADMISSION CAS WAS PERFORMED ON A 99% OCCLUDED LESION IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY OF 20MM IN LENGTH IN A 5.0MM VESSEL DIAMETER WITH MODERATE VESSEL TORTUOSITY. THE ARCH II LESION WAS MODERATELY CALCIFIED, ECCENTRIC AND ULCERATED. A 6MM EXTRA SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED PAST THE LESION WHICH WAS THEN PRE-DILATED FOLLOWED BY DEPLOYMENT OF AN 8X30MM PRECISE PRO RX STENT. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. THE ANGIOGUARD WAS SUCCESSFULLY REMOVED AND THERE WAS NO DEBRIS FOUND IN THE BASKET. THERE WAS NO DOCUMENTED DISSECTION. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE. THE PATIENT WAS DISCHARGED ON THE FOLLOWING DAY. RANKIN AND NIH STROKE SCALE SCORES WERE UNCHANGED. AT THE 30 DAY FOLLOW-UP NIH STROKE SCALE SCORE WAS 2 AND THE RANKIN WAS 0. THERE WERE NO REPORTED ADVERSE EVENTS. NINE MONTHS LATER THE PATIENT PRESENTED WITH COMPLAINTS OF A TINGLING SENSATION, NUMBNESS AND WEAKNESS IN THE RIGHT EXTREMITY WHILE WORKING. ON THE PREVIOUS DAY SHE ALSO HAD SOME MILD HEADACHE AND NUMBNESS TO THE RIGHT SIDE OF HER FACE AND ARMS. NEXT DAY SHE ALSO HAD ABRUPT WEAKNESS OF HER RIGHT ARM AND LEG THAT LASTED 20-30 MINUTES, SHE ALSO HAD A BRIEF EPISODE OF CONFUSION/LOSS OF CONSCIOUSNESS ASSOCIATED WITH DIZZINESS. ADMISSION NOTE INDICATED NOTED HISTORY OF PREVIOUS STROKE A PRIOR TO STENTING WITH RIGHT SIDED WEAKNESS THAT BE NOTED TO HAVE RESOLVED. PATIENT NOTED PREVIOUS STROKE HAD SIMILAR SYMPTOMS. NEUROLOGICAL REPORT NOTED THE PATIENT WAS ALERT, FULLY ORIENTED AND AWAKE WITH CRANIAL NERVES INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115790 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15146401

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R| S