BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 2435602 · Received February 1, 2012

    Report

    Report Number
    1058196-2012-00045
    Event Type
    Injury
    Date Received
    February 1, 2012
    Date of Event
    June 20, 2011
    Report Date
    January 19, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT FROM THE (B)(4) STUDY INDICATED THAT DURING AN ENTERPRISE VRD (ENC452812/01427234) ASSISTED COIL EMBOLIZATION OF A BASILAR-TIP ANEURYSM, THE PATIENT DEVELOPED CEREBRAL INFARCTION IN CEREBELLAR HEMISPHERES AND OCCIPITAL LOBES. ADDITIONALLY, THE PHYSICIAN NOTES THAT THE CEREBRAL INFARCTION OCCURRED IN THE PARTICULAR AREAS THAT WERE SERVED BY THE PARTICULAR VESSEL WHERE THE CATHETERS (PROWLER SELECT PLUS (606-S255X/LOT# UNKNOWN), TRAXSESS 14/TERUMO LAUNCHER/MEDTRONIC) WERE THREADED INTO AND PASSED THROUGH. ARGATROBAN HYDRATE WAS ADMINISTRATED FOR THE TREATMENT. THE EVENT OUTCOME WAS RECOVERED WITHOUT SEQUELAE. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS HIGHLY PROBABLE AND TO THE VRD WAS UNKNOWN. DURING THE EVENT, THE ENTERPRISE STENT WAS PATENT, AND WAS FULLY EXPANDED, APPOSED TO THE VESSEL WALL AND IN A STABLE POSITION. AFTER THE COILS WERE PLACE, NO COIL OR COILS PROTRUDED FROM THE TARGET ANEURYSM, AND THERE WERE NO COMPLICATIONS DURING THE PROCEDURE THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 8.5MM, AND THE NECK TO SAC RATIO WAS 8.5MM: 9.8MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 2.7MM AND DISTALLY WAS 2.2MM. THE PATIENT'S MEDICAL HISTORY CONSISTED OF STROKE (DETAILS UNKNOWN). THE ACT WAS 136 SECONDS PRE ANTICOAGULATION AND 421 SECONDS POST ANTICOAGULATION. THE MODIFIED RANKIN SCALE (MRS) SCORE PRE-PROCEDURE, POST PROCEDURE AND THREE AND A HALF MONTHS POST PROCEDURE WAS 2. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY FROM ONE WEEK PRE-PROCEDURE TO THREE MONTHS POST PROCEDURE AND CLOPIDOGREL 75MG/DAY ONGOING STARTING ONE WEEK PRE-PROCEDURE. THE OCCLUSION RATE OF ANEURYSM WAS 36% AFTER THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. THE PROWLER SELECT PLUS IS NOT AVAILABLE FOR ANALYSIS AND THE LOT NUMBER IS NOT KNOWN; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. CEREBRAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM AND THE PROCEDURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. DURING INTERVENTIONAL PROCEDURES, THE DEVICES ARE ADVANCED AND WITHDRAWN THROUGH ACCESSORY ARTERIES TO TREAT THE TARGET LESION. THE PHYSICAL MANIPULATION OF THE ARTERIES MAY RESULT IN EMBOLIZATION OF DEBRIS FROM THE INTIMAL LAYERS OF THESE ARTERIES. ALTHOUGH NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE EVENT AND THE DEVICES; THE PATIENT'S PRE-EXISTING MEDICAL HISTORY AND VESSEL CHARACTERISTICS, PROCEDURAL AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED. THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORTS 1058196-2012-00044 AND 1058196-2012-00045.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S MEDICAL HISTORY CONSISTED OF STROKE (DETAILS UNKNOWN). THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 8.5MM, AND THE NECK TO SAC RATIO WAS 8.5MM: 9.8MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 2.7MM AND DISTALLY WAS 2.2MM. MRS ON (B)(6) 2011 WAS 2, ON (B)(6) 2011 WAS 2, AND ON (B)(6) 2011 WAS 2. THE ACT WAS 136 SECONDS PRE ANTICOAGULATION AND 421 SECONDS POST ANTICOAGULATION. NO INFORMATION REGARDING INR, PT, AND PTT. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY:2011 (B)(6), CLOPIDOGREL SULFATE 75MG/DAY: 2011 (B)(6), AND ARGATROBAN HYDRATE 60MG/DAY:2011 (B)(6). THE OCCLUSION RATE OF ANEURYSM WAS 36% AFTER THE PROCEDURE. PRIOR TO IMPLANTING THE VRD, PROWLER SELECT PLUS ((B)(4)), TRAXSESS 14/TERUMO LAUNCHER/MEDTRONIC WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE, GT WIRE/TERUMO, V-TRACK(TERUMO)(TOTAL30). NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2012-00044 & 1058196-2012-00045.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATED THAT INSTEAD OF CEREBRAL INFARCTION, THE DIAGNOSIS WAS ASYMPTOMATIC CEREBRAL INFARCTION THAT WAS TREATED WITH HEPARIN 5000U AND ARGATROBAN HYDRATE ADMINISTERED INTRA-PROCEDURALLY. THE OCCLUSION RATE OF ANEURYSM WAS 95% AFTER THE PROCEDURE. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2012-00044 & 1058196-2012-00045.

    Description of Event or Problem · 1

    THE REPORT FROM THE CLINICAL STUDY (B)(4) FOR PATIENT (B)(6) INDICATED THAT INDEX PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH AN ENTERPRISE VRD ((B)(4)) OF BA-TIP, AND DURING THE PROCEDURE, THE PATIENT DEVELOPED CEREBRAL INFARCTION IN CEREBELLAR HEMISPHERES AND OCCIPITAL LOBES. ARGATROBAN HYDRATE WAS ADMINISTRATED FOR THE TREATMENT. THE EVENT OUTCOME WAS RECOVERED WITHOUT SEQUELAE. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS HIGHLY PROBABLE AND TO THE VRD WAS UNKNOWN. ADDITIONALLY, THE PHYSICIAN NOTES THAT THE CEREBRAL INFARCTION OCCURRED IN THE PARTICULAR AREAS THAT WERE SERVED BY THE PARTICULAR VESSEL WHERE THE CATHETERS (PROWLER SELECT PLUS ((B)(4)), TRAXSESS 14/TERUMO LAUNCHER/MEDTRONIC) WERE THREADED INTO AND PASSED THROUGH. AFTER THE COILS WERE PLACED, NO COIL OR COILS PROTRUDED FROM THE TARGET ANEURYSM, AND THERE WERE NO COMPLICATIONS DURING THE PROCEDURE THAT MAY HAVE CONTRIBUTED TO THE EVENT. DURING THE EVENT THE ENTERPRISE STENT WAS PATENT, AND WAS FULLY EXPANDED, APPOSE TO THE VESSEL WALL AND IN A STABLE POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention