BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 3222573 · Received July 12, 2013

    Report

    Report Number
    9616099-2013-00439
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 19, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. 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 15789409 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION/ADJUDICATION MINUTES RECEIVED AND REVIEWED INDICATED THAT THE COMMITTEE: DISAGREED WITH THE REPORTED STENT THROMBOSIS AND AGREED WITH TARGET VESSEL REVASCULARIZATION SURGERY - CLINICALLY DRIVEN AS PROCEDURE/DEVICE RELATED. POST-PROCEDURE, THE PATIENT DEVELOPED ACUTE RIGHT NECK EDEMA AND DUPLEX ULTRASOUND WAS PERFORMED TO RULE OUT AN ACUTE BLEED. DUPLEX ULTRASOUND FINDINGS WERE THE FOLLOWING, ACCORDING TO THE REPORT: ARTERIAL BLEED IN THE PROXIMAL RIGHT ICA STENT/VESSEL, FLOW VISUALIZED OUTSIDE OF THE STENT WITH A VELOCITY OF 145 CM/SEC. THE REPORT INDICATED THE LIMITED STUDY DUE TO ARTERIAL BLEED IN THE RIGHT ICA, NOTING THAT PRESSURE WAS RESUMED ON RIGHT NECK IMMEDIATELY AFTER THE BLEED WAS CONFIRMED WITH DUPLEX ULTRASOUND. A SURGERY WITH EXPLORATION OF THE RIGHT SIDE OF THE NECK, RIGHT CAROTID ENDARTERECTOMY, REPAIR OF CAROTID ARTERY AND BOVINE PERICARDIAL PATCH WAS PERFORMED. PER THE OPERATIVE NOTE, THE STENT WAS REMOVED DURING THE SURGERY. PRE-OPERATIVE AND POST-OPERATIVE DIAGNOSIS WAS AS FOLLOWS: RIGHT CAROTID ARTERY INJURY WITH POST-STENT BLEED. OPERATIVE REPORT NOTED THE AREA OF INJURY WAS LOCATED IN THE POSTEROLATERAL ASPECT OF THE PROXIMAL ICA, STATING THAT "THE ADVENTITIA IN THIS AREA HAS TORN THROUGH FULL THICKNESS." THE OPERATIVE SUMMARY REPORTED SUCCESSFUL SURGICAL TREATMENT WITH GOOD RESULTS. THE SITE REPORTED EVENTS OF STENT THROMBOSIS AND TARGET VESSEL REVASCULARIZATION. TWO DAYS POST-PROCEDURE/SURGERY, THE NIH STROKE SCALE SCORE WAS 0 AND THE RANKIN STROKE SCALE SCORE WAS 0. THE PATIENT WAS DISCHARGED THREE DAYS LATER ON ASA. NO ADDITIONAL SUPPORTING INFORMATION WAS PROVIDED AS TO WHY THE COMMITTED DISAGREED WITH THE REPORT OF THROMBOSIS IN DEVICE. AS SUCH, THE CODE OF STENT THROMBOSIS AS PREVIOUSLY REPORTED WILL REMAIN IN THE FILE AND THE ADVERSE EVENT/AE CODE OF ARTERIAL RUPTURE WILL BE ADDED. ADDITIONAL INFORMATION PROVIDED IN THE ADJUDICATION MINUTES INDICATED THAT THERE WAS DIFFICULTY RETRIEVING THE ANGIOGUARD EMBOLIC PROTECTION DEVICE SPECIFIED AS "CAPTURE SHEATH DID NOT ENGAGE FILTER" AND INABILITY TO CLOSE FILTER BASKET. PER CATHETERIZATION NOTE, THE RETRIEVAL CATHETER WAS HANGING UP ON THE STENT STRUTS, AND DESPITE MULTIPLE ATTEMPTS, RETRIEVAL SHEATH COULD NOT BE ADVANCED. UPON RETRIEVAL OF THE ANGIOGUARD NO DEBRIS WAS FOUND IN THE FILTER. THIS EVENT WAS NOT REPORTED/CAPTURED PREVIOUSLY AND WILL BE ADDED TO THE FILE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #9616099-2013-00439 AND #1016427-2013-00097.

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE PATIENT HAD A PRECISE 9 X 40 STENT SUCCESSFULLY IMPLANTED IN THE OSTIAL RIGHT INTERNAL CAROTID ARTERY (RICA) DURING THE STUDY INDEX PROCEDURE. A 5 MM. ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS USED. THE RESIDUAL STENOSIS WAS 25%. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED DURING THE PROCEDURE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. POST-PROCEDURE IN THE HOLDING/RECOVERY AREA THE PATIENT BECAME SYMPTOMATIC. THE PATIENT WAS TAKEN TO THE OR FOR AN EMERGENT ENDARTERECTOMY. THE PREVIOUSLY IMPLANTED PRECISE STENT WAS NOTED TO BE THROMBOSED. THE PATIENT WAS ANTICOAGULATED FOR THE INDEX PROCEDURE. THE PATIENT DID FINE POST-SURGERY. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE OSTIAL RICA TARGET LESION WAS REPORTED TO BE: A 99% STENOSIS, 15 MM. IN LENGTH, ABSENT OF THROMBUS, 6 MM. REFERENCE DIAMETER, SEVERELY CALCIFIED, NOT TORTUOUS, AND ULCERATED. THE LESION WAS PRE-DILATED. THE PATIENT WAS DISCHARGED FIVE DAYS AFTER THE PROCEDURE. ADDITIONAL INFORMATION/ADJUDICATION MINUTES RECEIVED AND REVIEWED INDICATED THAT THE COMMITTEE: DISAGREED WITH THE REPORTED STENT THROMBOSIS AND AGREED WITH TARGET VESSEL REVASCULARIZATION SURGERY - CLINICALLY DRIVEN AS PROCEDURE/DEVICE RELATED. POST-PROCEDURE, THE PATIENT DEVELOPED ACUTE RIGHT NECK EDEMA AND DUPLEX ULTRASOUND WAS PERFORMED TO RULE OUT AN ACUTE BLEED. DUPLEX ULTRASOUND FINDINGS WERE THE FOLLOWING, ACCORDING TO THE REPORT: ARTERIAL BLEED IN THE PROXIMAL RIGHT ICA STENT/VESSEL, FLOW VISUALIZED OUTSIDE OF THE STENT WITH A VELOCITY OF 145 CM/SEC. THE REPORT INDICATED THE LIMITED STUDY DUE TO ARTERIAL BLEED IN THE RIGHT ICA, NOTING THAT PRESSURE WAS RESUMED ON RIGHT NECK IMMEDIATELY AFTER THE BLEED WAS CONFIRMED WITH DUPLEX ULTRASOUND. A SURGERY WITH EXPLORATION OF THE RIGHT SIDE OF THE NECK, RIGHT CAROTID ENDARTERECTOMY, REPAIR OF CAROTID ARTERY AND BOVINE PERICARDIAL PATCH WAS PERFORMED. PER THE OPERATIVE NOTE, THE STENT WAS REMOVED DURING THE SURGERY. PRE-OPERATIVE AND POST-OPERATIVE DIAGNOSIS WAS AS FOLLOWS: RIGHT CAROTID ARTERY INJURY WITH POST-STENT BLEED. OPERATIVE REPORT NOTED THE AREA OF INJURY WAS LOCATED IN THE POSTEROLATERAL ASPECT OF THE PROXIMAL ICA, STATING THAT "THE ADVENTITIA IN THIS AREA HAS TORN THROUGH FULL THICKNESS." THE OPERATIVE SUMMARY REPORTED SUCCESSFUL SURGICAL TREATMENT WITH GOOD RESULTS. THE SITE REPORTED EVENTS OF STENT THROMBOSIS AND TARGET VESSEL REVASCULARIZATION. TWO DAYS POST-PROCEDURE/SURGERY, THE NIH STROKE SCALE SCORE WAS 0 AND THE RANKIN STROKE SCALE SCORE WAS 0. THE PATIENT WAS DISCHARGED THREE DAYS LATER ON ASA. NO ADDITIONAL SUPPORTING INFORMATION WAS PROVIDED AS TO WHY THE COMMITTED DISAGREED WITH THE REPORT OF THROMBOSIS IN DEVICE. AS SUCH, THE CODE OF STENT THROMBOSIS AS PREVIOUSLY REPORTED WILL REMAIN IN THE FILE AND THE ADVERSE EVENT/AE CODE OF ARTERIAL RUPTURE WILL BE ADDED. ADDITIONAL INFORMATION PROVIDED IN THE ADJUDICATION MINUTES INDICATED THAT THERE WAS DIFFICULTY RETRIEVING THE ANGIOGUARD EMBOLIC PROTECTION DEVICE SPECIFIED AS "CAPTURE SHEATH DID NOT ENGAGE FILTER" AND INABILITY TO CLOSE FILTER BASKET. PER CATHETERIZATION NOTE, THE RETRIEVAL CATHETER WAS HANGING UP ON THE STENT STRUTS, AND DESPITE MULTIPLE ATTEMPTS, RETRIEVAL SHEATH COULD NOT BE ADVANCED. UPON RETRIEVAL OF THE ANGIOGUARD NO DEBRIS WAS FOUND IN THE FILTER. THIS EVENT WAS NOT REPORTED/CAPTURED PREVIOUSLY AND WILL BE ADDED TO THE FILE. (B)(4): THE PRODUCT WAS NOT RETURNED FOR INSPECTION. 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 15789409 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BASED ON THE INFORMATION PROVIDED AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ARTERIAL RUPTURE/INJURY AND RESULTANT BLEEDING COMPLICATIONS ARE WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE CAN DISRUPT THE VESSEL PLAQUE AND INTIMA. 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. IN ADDITION, THE ARTERIAL RUPTURE ACCELERATED THE CLOTTING MECHANISM. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION INSIDE OF THE STENT. THERE ARE POSSIBLE PATIENT, VESSEL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #9616099-2013-00439 AND #1016427-2013-00097.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE SAPPHIRE STUDY INDICATED THAT THE PATIENT HAD A PRECISE 9 X 40 STENT SUCCESSFULLY IMPLANTED IN THE OSTIAL RIGHT INTERNAL CAROTID ARTERY (RICA) DURING THE STUDY INDEX PROCEDURE. A 5 MM. ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS USED. THE RESIDUAL STENOSIS WAS 25%. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED DURING THE PROCEDURE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE POST-PROCEDURE. POST-PROCEDURE IN THE HOLDING/RECOVERY AREA THE PATIENT BECAME SYMPTOMATIC. THE PATIENT WAS TAKEN TO THE OR FOR AN EMERGENT ENDARTERECTOMY. THE PREVIOUSLY IMPLANTED PRECISE STENT WAS NOTED TO BE THROMBOSED. THE PATIENT WAS ANTICOAGULATED FOR THE INDEX PROCEDURE. THE PATIENT DID FINE POST-SURGERY. NO ADDITIONAL INFORMATION WAS AVAILABLE. THE OSTIAL RICA TARGET LESION WAS REPORTED TO BE: A 99% STENOSIS, 15 MM. IN LENGTH, ABSENT OF THROMBUS, 6 MM. REFERENCE DIAMETER, SEVERELY CALCIFIED, NOT TORTUOUS, AND ULCERATED. THE LESION WAS PRE-DILATED. THE PATIENT WAS DISCHARGED FIVE DAYS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324018 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15789409

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R 5 MM. ANGIOGUARD