BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2883354 · Received December 21, 2012

    Report

    Report Number
    9616099-2012-00761
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PERSISTENT CONTRAST STASIS SUGGESTED THAT THE GUIDE CATHETER WAS OCCLUSIVE AND THE PATIENT WAS RE-EXAMINED IMMEDIATELY AFTER WITHDRAWING OF THE GUIDING CATHETER INTO THE DESCENDING AORTA, AND THE PATIENT'S SYMPTOMS RESOLVED ALMOST IMMEDIATELY. THE SITE REPORTED A 0% FINAL RESIDUAL STENOSIS WITH NO DISSECTION. THE CATHETERIZATION REPORT NOTED TRANSIENT GLOBAL APHASIA WITH GUIDE CATHETER IN PLACE, WHICH RESOLVED ONCE GUIDE CATHETER WAS REMOVED. THE DIAGNOSIS WAS A TRANSIENT ISCHEMIC ATTACK. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH ASPIRIN AND CLOPIDOGREL PRESCRIBED. AT THE 30-DAY FOLLOW-UP, THE PATIENT WAS HOSPITALIZED FOR LOSS OF VISION IN THE LEFT EYE. THE PATIENT REPORTS HE HAS HAD GRADUAL LOSS OF VISION SINCE DISCHARGE, BUT REALLY NOTICED A CHANGE ON THIS DAY. HE WAS SEEN BY OPTOMETRY WHO REPORTED THAT HE HAD AN OCCLUSION OF A BRANCH IN THE RETINAL ARTERY DUE TO MULTIPLE EMBOLI. A CT OF THE HEAD AND NECK REVEALED PATENT COMMON AND INTERNAL CAROTID ARTERY STENTS WHICH DEMONSTRATED 25% NARROWING SECONDARY TO MURAL THROMBOSIS AND COMPLETELY OCCLUDED LEFT EXTERNAL CAROTID ARTERY ORIGIN. THE PATIENT WAS STARTED ON COUMADIN AND HEPARIN DRIP TO BRIDGE HIM UNTIL THE PATIENT'S INR WAS THERAPEUTIC. "THE STROKE BUT DID NOT UNDERGO ANY ACUTE TREATMENT". THE PHYSICIAN BELIEVES THE EVENT WAS RELATED TO THE STENT AS THROMBUS WAS FOUND IN THE STENT ON CTA. THE PATIENT WAS DISCHARGED A WEEK LATER. CONCOMITANT DEVICES: PRECISE RX, ABBOTT FILTER, STERLING BALLOON, COOK GUIDECATHETER THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT #9616099-2012-00760 AND 9616099-2012-00761.

    Additional Manufacturer Narrative · 1

    AS REPORTED, APPROXIMATELY TWO WEEKS AFTER IN THE INDEX PROCEDURE THE PATIENT SUFFERED LOSS OF VISION IN THE EYE. CT IMAGING REVEALED AN ACUTE EMBOLIC SHOWER WITH MAJOR BRANCH RETINAL ARTERY OCCLUSION AND THROMBUS IN THE IMPLANTED PRECISE STENTS. CT ALSO DEMONSTRATED A NEW A POTENTIAL NEW LACUNAR INFARCT. THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC STROKE. THE PATIENT IS A (B)(6) MALE WHO UNDERWENT THE INDEX PROCEDURE WITH DELIVERY OF NON-STUDY EMBOLIC PROTECTION DEVICE (ABBOTT) AND PLACEMENT OF THE PRECISE ((B)(4)/LOT 15647002) STENT IN THE LEFT PROXIMAL INTERNAL CAROTID (ICA). THE ANGIOGUARD XP ECGW WAS NOT USED DUE TO ANTICIPATED DIFFICULTIES IN DELIVERING OF THE DEVICE VIA TIGHT LESION. POST-STENT BALLOON ANGIOPLASTY WAS PERFORMED. FOLLOWING THIS, AN ANGIOGRAM WAS PERFORMED TO RULE OUT SLUDGING OF EMBOLIC MATERIAL WITHIN THE DISTAL PROTECTION DEVICE. A PERSISTENT SLOW FLOW WAS PRESENT THROUGH A MORE PROXIMAL STENOSIS OF THE DISTAL LEFT COMMON CAROTID (CCA), THEREFORE, ANGIOPLASTY WITH A 5.5 X 20 STERLING BALLOON WAS PERFORMED, RESULTING IN DISSECTION OF UNSPECIFIED GRADE. THE DISSECTION WAS NOT WITHIN 5 MM OF THE ICA STENT AND TREATMENT OF THE ICA LESION WAS NOT FELT TO HAVE CAUSED THE DISSECTION IN THE LCCA. THE DISSECTION WAS TREATED WITH A PLACEMENT OF THE SECOND STUDY STENT ((B)(4)/ LOT 15661977). THE DISTAL PROTECTION DEVICE WAS REMOVED AND A CONTROL ANGIOGRAM WAS PERFORMED. PRIOR TO REMOVING THE COOK 6F SHUTTLE GUIDE CATHETER THE PATIENT WAS EXAMINED AND WAS FOUND TO BE APHASIC AND WEAK ON THE RIGHT SIDE. PERSISTENT CONTRAST STASIS SUGGESTED THAT THE GUIDE CATHETER WAS OCCLUSIVE AND THE PATIENT WAS RE-EXAMINED IMMEDIATELY AFTER WITHDRAWING OF THE GUIDING CATHETER INTO THE DESCENDING AORTA, AND THE PATIENT'S SYMPTOMS RESOLVED ALMOST IMMEDIATELY. THE SITE REPORTED A 0% FINAL RESIDUAL STENOSIS WITH NO DISSECTION. THE CATHETERIZATION REPORT NOTED TRANSIENT GLOBAL APHASIA WITH GUIDE CATHETER IN PLACE, WHICH RESOLVED ONCE GUIDE CATHETER WAS REMOVED. THE DIAGNOSIS WAS A TRANSIENT ISCHEMIC ATTACK. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH ASPIRIN AND CLOPIDOGREL PRESCRIBED. AT THE 30-DAY FOLLOW-UP, THE PATIENT WAS HOSPITALIZED FOR LOSS OF VISION IN THE LEFT EYE. THE PATIENT REPORTS HE HAS HAD GRADUAL LOSS OF VISION SINCE DISCHARGE BUT REALLY NOTICED A CHANGE ON THIS DAY. HE WAS SEEN BY OPTOMETRY WHO REPORTED THAT HE HAD AN OCCLUSION OF A BRANCH IN THE RETINAL ARTERY DUE TO MULTIPLE EMBOLI. A CT OF THE HEAD AND NECK REVEALED PATENT COMMON AND INTERNAL CAROTID ARTERY STENTS WHICH DEMONSTRATED 25% NARROWING SECONDARY TO MURAL THROMBOSIS AND COMPLETELY OCCLUDED LEFT EXTERNAL CAROTID ARTERY ORIGIN. THE PATIENT WAS STARTED ON COUMADIN AND HEPARIN DRIP TO BRIDGE HIM UNTIL THE PATIENT'S INR WAS THERAPEUTIC. THERE WAS NO ACUTE TREATMENT FOR THE STROKE. THE PHYSICIAN BELIEVES THE EVENT WAS RELATED TO THE STENT AS THROMBUS WAS FOUND IN THE STENT ON CTA. THE PATIENT WAS DISCHARGED A WEEK LATER. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AROUND THE DAMAGED AREAS. THROMBOSIS CAN CAUSE SERIOUS POST-PROCEDURAL COMPLICATIONS OF STENT OCCLUSION OR DISTAL EMBOLIZATION, RESULTING IN ACUTE CEREBRAL INFARCTION. ALTHOUGH THE INCIDENCE OF STROKE ATTRIBUTABLE TO ACUTE STENT THROMBOSIS IS UNCLEAR, A SUBSTANTIAL PROPORTION IS ASSUMED TO BE A DIRECT RESULT OF STENT THROMBOSIS OR AN INDIRECT RESULT BY DISTAL EMBOLIZATION. SEVERAL FACTORS, INCLUDING MECHANICAL PLAQUE DISRUPTION, INTIMAL INJURY, AND STENT THROMBOGENICITY PREDISPOSE THE PATIENT TO THROMBOEMBOLIC EVENTS. PLATELET ADHESION, ACTIVATION, AND AGGREGATION PLAY MAIN ROLES IN MURAL THROMBUS FORMATION. WITH THE INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL, PHARMACEUTICAL, AND PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT #9616099-2012-00760 AND 9616099-2012-00761.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY TWO WEEKS AFTER IN THE INDEX PROCEDURE THE PATIENT SUFFERED LOSS OF VISION IN THE EYE. CT IMAGING REVEALED AN ACUTE EMBOLIC SHOWER WITH MAJOR BRANCH RETINAL ARTERY OCCLUSION AND THROMBUS IN THE IMPLANTED PRECISE STENTS. CT ALSO DEMONSTRATED A NEW A POTENTIAL NEW LACUNAR INFARCT. THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC STROKE. THE PATIENT IS A (B)(6) MALE WHO UNDERWENT THE INDEX PROCEDURE WITH DELIVERY OF NON-STUDY EMBOLIC PROTECTION DEVICE (ABBOTT) AND PLACEMENT OF THE PRECISE ((B)(4)/LOT 15647002) STENT IN THE LEFT PROXIMAL INTERNAL CAROTID (ICA). THE ANGIOGUARD XP ECGW WAS NOT USED DUE TO ANTICIPATED DIFFICULTIES IN DELIVERING OF THE DEVICE VIA TIGHT LESION. POST-STENT BALLOON ANGIOPLASTY WAS PERFORMED. FOLLOWING THIS, AN ANGIOGRAM WAS PERFORMED TO RULE OUT SLUDGING OF EMBOLIC MATERIAL WITHIN THE DISTAL PROTECTION DEVICE. A PERSISTENT SLOW FLOW WAS PRESENT THROUGH A MORE PROXIMAL STENOSIS OF THE DISTAL LEFT COMMON CAROTID (CCA), THEREFORE, ANGIOPLASTY WITH A 5.5 X 20 STERLING BALLOON WAS PERFORMED, RESULTING IN DISSECTION OF UNSPECIFIED GRADE. THE DISSECTION WAS NOT WITHIN 5 MM OF THE ICA STENT AND TREATMENT OF THE ICA LESION WAS NOT FELT TO HAVE CAUSED THE DISSECTION IN THE LCCA. THE DISSECTION WAS TREATED WITH A PLACEMENT OF THE SECOND STUDY STENT ((B)(4)/LOT 15661977). THE DISTAL PROTECTION DEVICE WAS REMOVED AND A CONTROL ANGIOGRAM WAS PERFORMED. PRIOR TO REMOVING THE COOK 6F SHUTTLE GUIDE CATHETER THE PATIENT WAS EXAMINED AND WAS FOUND TO BE APHASIC AND WEAK ON THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15647002

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R