BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 3120182 · Received May 20, 2013

    Report

    Report Number
    9616099-2013-00309
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 24, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS BACK TO BASELINE BY THE END OF THE PROCEDURE AND THERE WERE NO MORE NEUROLOGICAL SYMPTOMS AFTER THAT. CONCOMITANT MEDICATIONS INCLUDED CLOPIDOGREL AT POST PROCEDURE AND AT DISCHARGE. ASPIRIN WAS ADMINISTERED AT PRE/POST PROCEDURE AND AT DISCHARGE. THE PHYSICIAN DOES NOT BELIEVE THIS WAS RELATED TO THE DEVICES. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 1016427-2013-00067. COMPLAINT CONCLUSION: AS REPORTED VIA THE (B)(6) REGISTRY, DURING A CAROTID INDEX PROCEDURE, THE PATIENT SHOWED SLOW FLOW TO NO FLOW THROUGH THE MID TO DISTAL LICA. THE PATIENT BECAME APHASIC AND EXPERIENCED SEVERELY LOW BLOOD PRESSURE. PRE-PROCEDURE NIH STROKE SCALE WAS 3 AND THE STROKE SCALE WAS 0. THE PATIENT WAS SYMPTOMATIC. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 95% STENOSIS TO THE LEFT OSTIAL INTERNAL CAROTID ARTERY. THE LESION WAS DESCRIBED AS 25MM IN LENGTH, SEVERELY CALCIFIED, ARCH TYPE II AND ECCENTRIC. THE REFERENCE VESSEL WAS 8.0 IN DIAMETER WITH SEVERE TORTUOSITY. A 7MM ANGIOGUARD WAS DEPLOYED SUCCESSFULLY BEYOND THE TARGET LESION AND THE LESION WAS PRE-DILATED. A 8.0 X 30MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION. THE ANGIOGUARD WAS RETRIEVED AND DEBRIS WAS NOTED IN THE FILTER BASKET. THERE WERE NO AIR BUBBLES PRESENT DURING THE PROCEDURE. AFTER POST-DILATION WITH AN AVIATOR PLUS 5.0 X 20 MM (LOT# UNKNOWN), THE BALLOON SYSTEM WAS REMOVED AND THE ANGIOGRAPHY SHOWED SLOW FLOW TO NO FLOW THROUGH THE MID TO DISTAL LICA, INDICATING HEAVY DEBRIS IN THE FILTER. THIS IS WHEN THE PATIENT BECAME SYMPTOMATIC, WITH APHASIA AND NOT FOLLOWING COMMANDS. SHE DID MAKE EYE CONTACT AND FOLLOW VISUALLY APPROPRIATELY. THE PHYSICIAN GAVE INTRACAROTID NITROGLYCERIN THEN MADE TO 2 RUNS WITH AN EXPORT CATHETER WHICH REMOVED 30 ML. AFTER THIS, THE ANGIOGRAPHY SHOWED BRISK FLOW. THE PATIENT WAS ALSO EXPERIENCING SEVERELY LOW BLOOD PRESSURE AND WAS TREATED WITH MEDICATIONS. HER NEUROLOGICAL SYMPTOMS WENT BACK TO BASELINE AND HER BLOOD PRESSURE IMPROVED BY THE END OF THE PROCEDURE. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NEUROLOGICAL DEFICITS. NO ADDITIONAL DIAGNOSTIC PROCEDURES WERE DONE. THE DURATION OF SYMPTOMS WAS LESS THAN 24 HOURS AND FULLY RESOLVED WITH NO DEFICITS. THE POST NIH STROKE SCALE WAS 3, THE POST STROKE SCALE WAS 0 AND THE PATIENT WAS DISCHARGED THE NEXT DAY. THERE WAS NO CHANGE FROM BASELINE TO POST PROCEDURE IN THE STROKE SCALE. THE PATIENT¿S MEDICAL HISTORY INCLUDES HYPERLIPIDEMIA, CLINICAL COPD, CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, CORONARY PERCUTANEOUS REVASCULARIZATION, HYPERTENSION (SYSTOLIC>140, OR DIASTOLIC>90, OR REQUIRING MEDICATION) AND A HIGH RISK CRITERIA OF AGE GREATER THAN 75. (B)(4) THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 10189496 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. APHASIA, AS A SYMPTOM OF TIA, IS A WELL-KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. 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. HYPOTENSION AND HYPOPERFUSION ARE WELL-KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. THE HEMODYNAMIC INSTABILITY THAT OCCURS BOTH DURING AND AFTER CAROTID STENT IMPLANTATION IS INFLUENCED BY THE BARO-RECEPTORS, WHICH ARE LOCATED AT THE CAROTID BIFURCATION. THESE BARO-RECEPTORS ARE STIMULATED BY THE STRETCH OF INTERVENTIONAL BALLOONS, SDS (STENT DELIVERY SYSTEM) AND DISTAL PROTECTION DEVICES, INITIATING A REFLEX VIA THE GLOSSOPHARYNGEAL NERVE. THIS RESULTS IN A FALL IN BLOOD PRESSURE AND BRADYCARDIA. STENT PLACEMENT MAY PROMOTE PERSISTENT STIMULATION OF THESE BARO-RECEPTORS. THESE REACTIONS ARE ANTICIPATED RELATIVELY SHORT-TERM ADVERSE EVENTS ASSOCIATED WITH THE COMPRESSION OF THE BARO-RECEPTORS DURING BALLOON INFLATION, STENT IMPLANTATION AND FILTER DEVICE MANIPULATION. 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. THEREFORE, NO ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(6) REGISTRY, DURING A CAROTID INDEX PROCEDURE, THE PATIENT SHOWED SLOW FLOW TO NO FLOW THROUGH THE MID TO DISTAL LICA. THE PATIENT BECAME APHASIC AND EXPERIENCED SEVERELY LOW BLOOD PRESSURE. PRE-PROCEDURE NIH STROKE SCALE WAS 3 AND THE STROKE SCALE WAS 0. THE PATIENT WAS SYMPTOMATIC. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 95% STENOSIS TO THE LEFT OSTIAL INTERNAL CAROTID ARTERY. THE LESION WAS DESCRIBED AS 25MM IN LENGTH, SEVERELY CALCIFIED, ARCH TYPE II AND ECCENTRIC. THE REFERENCE VESSEL WAS 8.0 IN DIAMETER WITH SEVERE TORTUOSITY. A 7MM ANGIOGUARD WAS DEPLOYED SUCCESSFULLY BEYOND THE TARGET LESION AND THE LESION WAS PRE-DILATED. A 8.0 X 30MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION. THE ANGIOGUARD WAS RETRIEVED AND DEBRIS WAS NOTED IN THE FILTER BASKET. THERE WERE NO AIR BUBBLES PRESENT DURING THE PROCEDURE. AFTER POST-DILATION WITH AN AVIATOR PLUS 5.0 X 20 MM (LOT# UNKNOWN), THE BALLOON SYSTEM WAS REMOVED AND THE ANGIOGRAPHY SHOWED SLOW FLOW TO NO FLOW THROUGH THE MID TO DISTAL LICA, INDICATING HEAVY DEBRIS IN THE FILTER. THIS IS WHEN THE PATIENT BECAME SYMPTOMATIC, WITH APHASIA AND NOT FOLLOWING COMMANDS. SHE DID MAKE EYE CONTACT AND FOLLOW VISUALLY APPROPRIATELY. THE PHYSICIAN GAVE INTRACAROTID NITROGLYCERIN THEN MADE TO 2 RUNS WITH AN EXPORT CATHETER WHICH REMOVED 30 ML. AFTER THIS, THE ANGIOGRAPHY SHOWED BRISK FLOW. THE PATIENT WAS ALSO EXPERIENCING SEVERELY LOW BLOOD PRESSURE AND WAS TREATED WITH MEDICATIONS. HER NEUROLOGICAL SYMPTOMS WENT BACK TO BASELINE AND HER BLOOD PRESSURE IMPROVED BY THE END OF THE PROCEDURE. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NEUROLOGICAL DEFICITS. NO ADDITIONAL DIAGNOSTIC PROCEDURES WERE DONE. THE DURATION OF SYMPTOMS WAS LESS THAN 24 HOURS AND FULLY RESOLVED WITH NO DEFICITS. THE POST NIH STROKE SCALE WAS 3, THE POST STROKE SCALE WAS 0 AND THE PATIENT WAS DISCHARGED THE NEXT DAY. THERE WAS NO CHANGE FROM BASELINE TO POST PROCEDURE IN THE STROKE SCALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222661 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15812077

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR