BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 3501232 · Received December 5, 2013

    Report

    Report Number
    9616099-2013-00772
    Event Type
    Injury
    Date Received
    December 5, 2013
    Date of Event
    September 27, 2013
    Report Date
    November 12, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VISUAL DEFICIT WAS ALSO ACCOMPANIED WITH THE SENSATION OF AN OBJECT IMPAIRING HIS VISION CONSTANTLY. THERE WERE NO FLASHES OF LIGHT OR FLOATERS. THE PATIENT SAW AN EYE DOCTOR WHO SAID THERE WAS A POSSIBLE CLOT TO THAT AREA, BUT IT WAS RESOLVING AND HE DIDN¿T EXPECT THE SUBJECT TO HAVE ANY PERMANENT CHANGES. SUBJECT¿S VISION HAS IMPROVED SINCE THAT TIME, HOWEVER, HE STILL HAS RESIDUAL VISUAL DEFICITS. THERE WERE NO OTHER NEUROLOGIC CHANGES. THE PATIENT IS CURRENTLY IN STABLE CONDITION. DURING THE 30-DAY FOLLOW-UP, THE NIH SCORE WAS 26, AND THE RANKIN SCORE WAS 1. THE DEVICE IS IMPLANTED, THEREFORE THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. A 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. CONCOMITANT MEDICATIONS: BIVALIRUDIN WAS GIVEN DURING THE PROCEDURE. PRE AND POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. CONCOMITANT DEVICES: 6FRX90CM SHUTTLE SELECT SHEATH INTRODUCER, COOK INCORPORATED; 5.5 FR X 125CM JB1 COOK INCORPORATED GUIDING CATHETER; ANGIOGUARD RX, CATALOG # 701814RMC, LOT # 70413403; AND CORDIS AVIATOR PLUS 4X20MM BALLOON CATHETER.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NIH/RANKIN PERFORMER REVIEWED THE 30 DAY STROKE SCALE AND CORRECTED A FEW MISTAKES. THE 30 DAY NIH STROKE SCALE WAS ACTUALLY A SCORE OF ¿7¿. COMPLAINT CONCLUSION: AS REPORTED BY THE SAPPHIRE REGISTRY, A 9X40MM PRECISE PRO RX STENT WAS UNABLE TO DEPLOY AT THE TARGET LESION DUE TO A BENT METAL HYPOTUBE OF THE STENT DELIVERY SYSTEM (SDS). THE SDS WAS THEN REMOVED AND REPLACED WITH ANOTHER 9X40MM PRECISE PRO RX STENT, WHICH WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE DAY AFTER THE PATIENT WAS DISCHARGED, THE PATIENT EXPERIENCED A SUDDEN ONSET OF A LEFT VISUAL FIELD LOSS DUE TO A BRANCH RETINAL ARTERY OCCLUSION. THE PATIENT¿S VISION IS IMPROVING, YET THERE IS STILL A VISUAL DEFICIT. THE PATIENT IS CURRENTLY IN STABLE CONDITION. THE PATIENT IS AN (B)(6) MALE WITH A MEDICAL HISTORY OF ATRIAL FIBRILLATION, CARDIAC ARRHYTHMIA, HISTORY OF TIA, HISTORY OF SMOKING, DIABETES, AND HYPERTENSION. THE PATIENT HAD AN ECCENTRIC TARGET LESION WITH A LENGTH OF 20MM AND A DIAMETER OF 7MM LOCATED IN THE LEFT PROXIMAL INTERNAL CAROTID ARTERY. THE LESION WAS MILDLY CALCIFIED WITH THE CALCIFICATION WIDTH GREATER OR EQUAL TO 3MM. THE VESSEL WAS MILDLY TORTUOUS WITH 2 OR MORE BENDS WITHIN 5CM OF THE LESION. THE BASELINE NIH AND RANKIN STROKE SCALE SCORES WERE BOTH 0. DURING THE PROCEDURE, APPROACH WAS MADE WITH A 6F NON-CORDIS SHEATH AND A 5.5F NON-CORDIS GUIDING CATHETER. A 7MM ANGIOGUARD RX EMBOLIC PROTECTION DEVICE WAS INSERTED AND SUCCESSFULLY DEPLOYED PAST THE LESION. PRE-DILATION WAS PERFORMED WITH A 4X20MM AVIATOR PLUS AT 8 ATMOSPHERES WITH A RESIDUAL STENOSIS OF 50%. THEN A 9X40MM PRECISE PRO RX STENT WAS INSERTED AND DELIVERED TO THE TARGET LESION. HOWEVER, THE PHYSICIAN WAS UNABLE TO DEPLOY THE STENT AND REMOVED THE SDS. IT WAS FOUND THAT THE DEPLOYMENT MECHANISM APPEARED TO BE FAULTY DUE TO A BENT METAL HYPOTUBE. THE SDS WAS REPLACED WITH ANOTHER 9X40MM PRECISE PRO RX STENT, AND IT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE FINAL TARGET LESION STENOSIS PERCENTAGE WAS 0. THE PATIENT WAS DISCHARGED THE NEXT DAY WITHOUT ANY PATIENT INJURY. THE NIH AND RANKIN SCORE AT DISCHARGE WAS 0. THE DAY AFTER DISCHARGE, THE PATIENT SUFFERED A SUDDEN ONSET OF LEFT VISUAL FIELD LOSS DUE TO A BRANCH RETINAL ARTERY OCCLUSION. THE VISUAL DEFICIT WAS ALSO ACCOMPANIED WITH THE SENSATION OF AN OBJECT IMPAIRING HIS VISION CONSTANTLY. THERE WERE NO FLASHES OF LIGHT OR FLOATERS. THE PATIENT SAW AN EYE DOCTOR WHO SAID THERE WAS A POSSIBLE CLOT TO THAT AREA, BUT IT WAS RESOLVING AND HE DIDN¿T EXPECT THE SUBJECT TO HAVE ANY PERMANENT CHANGES. SUBJECT¿S VISION HAS IMPROVED SINCE THAT TIME; HOWEVER, HE STILL HAS RESIDUAL VISUAL DEFICITS. THERE WERE NO OTHER NEUROLOGIC CHANGES. THE PATIENT IS CURRENTLY IN STABLE CONDITION. DURING THE 30-DAY FOLLOW-UP, THE NIH SCORE WAS 7, AND THE RANKIN SCORE WAS 1. THIS DEVICE IS IMPLANTED IN THE PATIENT; THEREFORE THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW OF THE LOT WAS CONDUCTED AND PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15936092 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE IFU STATES TO EXAMINE THE PRODUCT FOR ANY DAMAGES PRIOR TO USAGE. IF A DEFECT IS FOUND, DO NOT USE THE PRODUCT IN THE PROCEDURE. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, THE COMPLAINT OF ¿DEPLOYMENT DIFFICULTY-UNABLE¿ COULD BE RELATED TO THE CONDITION OF THE DEVICE (KINKED/BENT). HOWEVER, IT IS NOT POSSIBLE TO DETERMINE THE EXACT FACTORS OF WHAT MAY HAVE CONTRIBUTED TO THIS REPORTED ISSUE. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINTS, ¿STAINLESS STEEL HYPOTUBE/ KINKED/BENT¿ AND ¿STENT DELIVERY SYSTEM/DEPLOYMENT DIFFICULTY-UNABLE,¿ COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. BASED ON THE DEVICE HISTORY RECORD REVIEW FOR THIS PRODUCT, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. A BRANCH RETINAL ARTERY OCCLUSION (BRAO) OCCURS WHEN ONE OF THE BRANCHES OF THE ARTERIAL SUPPLY TO THE RETINA BECOMES OCCLUDED. MOST COMMONLY, A BRAO OCCURS SECONDARY TO AN EMBOLUS. EMBOLI TYPICALLY ORIGINATE WITHIN VESSELS UPSTREAM WHERE THEY DISLODGE AND TRAVEL WITHIN THE CIRCULATORY SYSTEM TO ULTIMATELY BECOME LODGED DOWNSTREAM IN A VESSEL WITH A SMALLER LUMEN. THE MOST COMMON INCLUDE CHOLESTEROL EMBOLI FROM AORTO-CAROTID ATHEROMATOUS PLAQUES, PLATELET-FIBRIN EMBOLI FROM THROMBOTIC DISEASE, AND CALCIFIC EMBOLI FROM CARDIAC VALVULAR DISEASE. PATIENTS WITH BRAO TYPICALLY PRESENT WITH ACUTE, UNILATERAL, PAINLESS, PARTIAL VISUAL LOSS. VISUAL FIELD DEFECTS MAY BE CENTRAL OR SECTORAL. PATIENTS MAY ALSO BE ASYMPTOMATIC. RISK FACTORS INCLUDE SMOKING, HYPERTENSION, HYPERCHOLESTEROLEMIA, DIABETES, CORONARY ARTERY DISEASE, OR HISTORY OF STROKE OR TRANSIENT ISCHEMIC ATTACK (TIA). SEVENTY-FIVE PERCENT OF PATIENTS SUFFERING FROM BRAO HAVE HYPERTENSION OR CAROTID OCCLUSIVE DISEASE. IN THIS CASE, THE PATIENT HAD RECEIVED STENTING OF A TARGET LESION IN THE LEFT PROXIMAL INTERNAL CAROTID ARTERY, AND THE EMBOLI COULD HAVE DISLODGED FROM THE TREATED TARGET LESION. THE PATIENT ALSO HAS A HISTORY OF A PREVIOUS TIA, HISTORY OF SMOKING, DIABETES, AND HYPERTENSION THAT MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT MANUFACTURING ISSUES CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, PHARMACEUTICAL, VESSEL AND/OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) REGISTRY, A 9X40MM PRECISE PRO RX STENT WAS UNABLE TO DEPLOY AT THE TARGET LESION DUE TO A BENT METAL HYPOTUBE OF THE STENT DELIVERY SYSTEM (SDS). THE SDS WAS THEN REMOVED AND REPLACED WITH ANOTHER 9X40MM PRECISE PRO RX STENT, WHICH WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE DAY AFTER THE PATIENT WAS DISCHARGED, THE PATIENT EXPERIENCED A SUDDEN ONSET OF A LEFT VISUAL FIELD LOSS DUE TO A BRANCH RETINAL ARTERY OCCLUSION. THE PATIENT¿S VISION IS IMPROVING, YET THERE IS STILL A VISUAL DEFICIT. THE PATIENT IS CURRENTLY IN STABLE CONDITION. THE PATIENT HAD AN ECCENTRIC TARGET LESION WITH A LENGTH OF 20MM AND A DIAMETER OF 7MM LOCATED IN THE LEFT PROXIMAL INTERNAL CAROTID ARTERY. THE LESION WAS MILDLY CALCIFIED WITH THE CALCIFICATION WIDTH GREATER OR EQUAL TO 3MM. THE VESSEL WAS MILDLY TORTUOUS WITH 2 OR MORE BENDS WITHIN 5CM OF THE LESION. THE BASELINE NIH AND RANKIN STROKE SCALE SCORES WERE BOTH 0. DURING THE PROCEDURE, APPROACH WAS MADE WITH A 6F NON-CORDIS SHEATH AND A 5.5F NON-CORDIS GUIDING CATHETER. A 7MM ANGIOGUARD RX EMBOLIC PROTECTION DEVICE WAS INSERTED AND SUCCESSFULLY DEPLOYED PAST THE LESION. PRE-DILATION WAS PERFORMED WITH A 4X20MM AVIATOR PLUS AT 8 ATMOSPHERES WITH 165ML OF VISIPAQUE, MAKING THE TARGET LESION AT 50% STENOSED. THEN A 9X40MM PRECISE PRO RX STENT WAS INSERTED AND DELIVERED TO THE TARGET LESION. HOWEVER, THE PHYSICIAN WAS UNABLE TO DEPLOY THE STENT AND REMOVED THE SDS. IT WAS FOUND THAT THE DEPLOYMENT MECHANISM APPEARED TO BE FAULTY DUE TO A BENT METAL HYPOTUBE. THE SDS WAS REPLACED WITH ANOTHER 9X40MM PRECISE PRO RX STENT, AND IT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION. THE FINAL TARGET LESION STENOSIS PERCENTAGE WAS 0. THE PATIENT WAS DISCHARGED THE NEXT DAY WITHOUT ANY PATIENT INJURY. THE NIH AND RANKIN SCORE AT DISCHARGE WAS 0. THE DAY AFTER DISCHARGE, THE PATIENT SUFFERED A SUDDEN ONSET OF LEFT VISUAL FIELD LOSS DUE TO A BRANCH RETINAL ARTERY OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630091 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15936092

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Disability