BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1739280 · Received June 29, 2010

    Report

    Report Number
    9616099-2010-00486
    Event Type
    Injury
    Date Received
    June 29, 2010
    Date of Event
    May 28, 2010
    Report Date
    June 3, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRECISE 8 X 40 STENT WAS CHOSEN AND WITH SOME DIFFICULTY THIS WAS PASSED BEYOND THE LESION AND THEN DEPLOYED WITHOUT DIFFICULTY. THIS WAS ATTEMPTED TO BE BALLOONED WITH A 5 X 40 BALLOON THOUGH THIS WOULD NOT TRACK. AN ARTERIOGRAM WAS PERFORMED AND THIS SHOWED THAT THERE WAS A SIGNIFICANT KINK IN THE STENT AT THE AREA OF THE SECOND STENOSIS WHERE THE LARGE CALCIFIC PLAQUE WAS NOTED. THIS WAS BALLOONED WITH A 3X20 BALLOON. POST ARTERIOGRAM SHOWED THIS TO BE PATENT THOUGH STILL SIGNIFICANT. A 5X20 BALLOON WAS USED TO ANGIOPLASTY THIS AND THERE WAS STILL SIGNIFICANT KINK NOTED. A 6X20 BALLOON WAS USED AS WELL, AND THE KINK PERSISTED. IT WAS FELT THIS WOULD BE THE BEST RESULT POSSIBLE. OF NOTE AN ARTERIOGRAM THROUGH THE SHEATH SHOWED SIGNIFICANT SPASM WITH SLUGGISH FLOW THROUGH THE INTERNAL CAROTID ARTERY. THE PATIENT REMAINED NEUROLOGICALLY INTACT THROUGHOUT. WITH EXTENSIVE EFFORT AND MULTIPLE ATTEMPTS, THE CAPTURE CATHETER WAS EVENTUALLY ABLE TO BE PASSED THROUGH THE LESION AND THE FILTER WAS CAPTURED WITHOUT DIFFICULTY. THE WIRE AND CAPTURE CATHETER WERE REMOVED. AN ARTERIOGRAM WAS PERFORMED THROUGH THE SHEATH WHICH SHOWED PROMPT FLOW THROUGH THE STENT AND INTO THE DISTAL INTERNAL CAROTID ARTERY. THERE WAS STILL A RESIDUAL STENOSIS AT THE SITE OF THE CALCIFIED PLAQUE THOUGH IN MULTIPLE ANGLES FLOW DID SEEM IMPROVED FROM THE INITIAL PICTURE PRIOR TO INTERVENTION. THE STENOSIS AT THE DISTAL COMMON CAROTID ARTERY WAS DEFINITELY IMPROVED. OF NOTE THE PATIENT WAS RE-BOLUSED WITH HEPARIN AT EACH ADDITIONAL HOUR. THE SHEATH WAS REMOVED. THE ACCESS SITE WAS CLOSED WITH A STARCLOSE DEVICE WITHOUT DIFFICULTY. THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS NEUROLOGICALLY INTACT AND FOLLOWING COMMANDS AT THE END OF THE CASE. SHE WAS TAKEN TO THE RECOVERY ROOM AND THEN MOVED TO THE ICU WITH CONTINUED CARE. WITH THE LATER ANGIOPLASTY AND PLACEMENT OF THE STENT, SHE DID HAVE SOME BRADYCARDIA AND HYPOTENSION WHICH REQUIRED ATROPINE AND NEO THOUGH SHE DID RESPONSE TO THESE WELL. CONCOMITANT PRODUCTS: HEPARIN, ASPIRIN, CLOPIDOGREL, ATROPINE, NEOSYNEPHRINE CONCOMITANT DEVICES: 3X20 STERLING MONORAIL BALLOON, 6X20 AVIATOR BALLOON. 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 THREE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 1016427-2010-00072, 9610978-2010-00131, AND 9616099-2010-00486.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA THE (B)(4) STUDY THAT A PRECISE CAROTID STENTING PROCEDURE WITH USE OF AN ANGIOGUARD EMBOLIC PROTECTION DEVICE, A 4X20 AVIATOR BALLOON FOR PREDILATION, AND A 5X20 AVIATOR BALLOON FOR POST DILATION WAS PERFORMED IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). IT WAS INDICATED THAT THERE WAS AN ANGIOGUARD RX MALFUNCTION DURING THE INDEX PROCEDURE. ADDITIONAL INFORMATION REPORTED THAT DUE TO VESSEL CHARACTERISTICS THERE WAS DIFFICULTY RETRIEVING THE ANGIOGUARD. RECEIVED INFORMATION ALSO INDICATED THAT DURING THE PROCEDURE THERE WAS SELF LIMITING VESSEL SPASM DURING PREDILATION AND AT THE END OF THE PROCEDURE PRIOR TO REMOVAL OF THE ANGIOGUARD. IN ADDITION, THERE WAS HYPOTENSION AND BRADYCARDIA RELATED TO STENT PLACEMENT AND POST DILATION WHICH REQUIRED MEDICAL TREATMENT. AT INDEX PROCEDURE, THE (B)(6) FEMALE'S MEDICAL HISTORY INCLUDED RADICAL NECK DISSECTION AND RADIATION TO THE RIGHT NECK. THE PATIENT WAS NOTED TO HAVE A HIGH-GRADE STENOSIS AT THE ORIGIN OF THE INTERNAL CAROTID ARTERY AND A SECOND STENOSIS OF AT LEAST 85% APPROXIMATELY 2 CM BEYOND THE ORIGIN. THE PATIENT WAS GIVEN 2,000 UNITS OF HEPARIN PRIOR TO ACCESSING THE ORIGIN OF THE COMMON CAROTID ARTERY. SHE WAS GIVEN AN ADDITIONAL 3,000 UNITS OF HEPARIN PRIOR TO PLACING THE SHEATH. THERE IS NOTED SIGNIFICANT CALCIFIC PLAQUE. THE EMBOLIC PROTECTION DEVICE WAS PASSED THROUGH A SHUTTLE SHEATH AND DEPLOYED WITHOUT DIFFICULTY. DUE TO THE SIGNIFICANT NARROWING WITHIN THE PROXIMAL INTERNAL CAROTID ARTERY, A 4X20 AVIATOR BALLOON WAS USED TO PRE-DILATE THE LESION. THE PATIENT TOLERATED THIS WELL. POST ARTERIOGRAM SHOWED EVIDENCE OF SOME SPASM WITHIN THE INTERNAL CAROTID ARTERY, NO SIGNIFICANT THROMBUS OR FILLING DEFECTS WERE NOTED WITHIN THE CAROTID ARTERY. A PRECISE 8 X 40 STENT WAS DEPLOYED WITHOUT DIFFICULTY. THIS WAS ATTEMPTED TO BE BALLOONED WITH AN UNKNOWN 5X40 BALLOON THOUGH THIS WOULD NOT TRACK. AN ARTERIOGRAM WAS PERFORMED AND THIS SHOWED THAT ALTHOUGH THERE WAS GOOD WALL APPOSITION THERE WAS A SIGNIFICANT KINK IN THE STENT AT THE AREA OF THE SECOND STENOSIS WHERE THE LARGE CALCIFIC PLAQUE WAS NOTED. THIS WAS BALLOONED WITH A 3X20 BALLOON. POST ARTERIOGRAM SHOWED THIS TO BE PATENT WITH GOOD STENT WALL APPOSITION THOUGH STILL SIGNIFICANT KINKING DUE TO THE PLAQUE. A 5X20 BALLOON WAS USED TO ANGIOPLASTY THIS AND THERE WAS STILL SIGNIFICANT KINK NOTED. A 6X20 BALLOON WAS USED AS WELL AND THE KINK PERSISTED. IT WAS FELT THIS WOULD BE THE BEST RESULT POSSIBLE. THERE WAS BRADYCARDIA AND HYPOTENSION WITH THE LATER ANGIOPLASTY AND PLACEMENT OF THE STENT. THIS REQUIRED ATROPINE AND NEO WITH GOOD RESPONSE. POST DILATION PRIOR TO REMOVAL OF THE ANGIOGUARD, ARTERIOGRAM THROUGH THE SHEATH SHOWED SIGNIFICANT SPASM WITH SLUGGISH FLOW THROUGH THE INTERNAL CAROTID ARTERY. THE PATIENT REMAINED NEUROLOGICALLY INTACT THROUGHOUT. INFORMATION INDICATED THAT AFTER EXTENSIVE EFFORT AND MULTIPLE ATTEMPTS THE ANGIOGUARD WAS PASSED THROUGH THE LESION AND THE FILTER WAS CAPTURED WITHOUT DIFFICULTLY. HOWEVER, WITH INVESTIGATION IT WAS REPORTED THAT THE PROBLEM WAS THAT DURING RETRIEVAL DELIVERY OF THE CAPTURE SHEATH THE PATIENT'S HISTORY OF NECK RADIATION AND A VERY TIGHT ECCENTRIC CALCIFICATION MADE IT DIFFICULT TO MANEUVER THROUGH. IT WAS REPORTED THAT THERE WAS NO PROBLEM WITH THE PRODUCT; IT COULD NOT BE DETERMINED IF THE ANGIOGUARD GOT STUCK ON ONE OF THE STRUTS OF THE STENT OR WHETHER IT WAS JUST DUE TO THE ANATOMY. EVENTUALLY THE ANGIOGUARD WAS REMOVED. AN ARTERIOGRAM WAS PERFORMED THROUGH THE SHEATH WHICH SHOWED PROMPT FLOW THROUGH THE STENT AND INTO THE DISTAL INTERNAL CAROTID ARTERY. THERE WAS STILL A RESIDUAL STENOSIS AT THE SITE OF THE CALCIFIED PLAQUE THOUGH IN MULTIPLE ANGLES FLOW DID SEEM IMPROVED FROM THE INITIAL PICTURE PRIOR TO INTERVENTION. IT WAS REPORTED THAT THERE WAS GOOD WALL APPOSITION OF THE STENT. THE STENOSIS AT THE DISTAL COMMON CAROTID ARTERY WAS DEFINITELY IMPROVED. OF NOTE THE PATIENT WAS RE-BOLUSED WITH HEPARIN AT EACH ADDITIONAL HOUR. THE SHEATH WAS REMOVED. THE ACCESS SITE WAS CLOSED WITH A STARCLOSE DEVICE WITHOUT DIFFICULTY. THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS NEUROLOGICALLY INTACT AND FOLLOWING COMMANDS AT THE END OF THE CASE. SHE WAS TAKEN TO THE RECOVERY ROOM AND THEN MOVED TO THE ICU WITH CONTINUED CARE. THE PRECISE STENT REMAINS IMPLANTED AND THE DELIVERY SYSTEM IS NOT AVAILABLE FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. HEMODYNAMIC DEPRESSION, INCLUDING HYPOTENSION AND BRADYCARDIA, DURING CAROTID ARTERY STENTING PROCEDURES IS A COMMON EVENT AND IS MOST LIKELY RELATED TO CORONARY SINUS REFLEX OR VAGAL RESPONSE. THE VAGUS NERVE ENTERS THE THORAX BETWEEN COMMON CAROTID ARTERY AND SUBCLAVIAN ARTERY AND DESCENDS DOWNWARD. DURING BALLOON INFLATION OR STENT DEPLOYMENT, PRESSURE CAN BE EXERTED ON THE NERVE STIMULATING A PARASYMPATHETIC RESPONSE, I.E. BRADYCARDIA, HYPOTENSION, HEART BLOCK, ETC. THERE IS NO EVIDENCE TO SUGGEST THAT THESE EVENTS ARE RELATED TO A DEVICE DESIGN OR MANUFACTURING ISSUE. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENTS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF THREE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 1016427-2010-00072, 9610978-2010-00131, AND 9616099-2010-00486.

    Description of Event or Problem · 1

    DURING ANGIOPLASTY AND PLACEMENT OF THE STENT, THE PATIENT HAD SOME BRADYCARDIA AND HYPOTENSION WHICH REQUIRED MEDICAL TREATMENT. THE PATIENT IS A (B)(6) FEMALE WITH A MEDICAL HISTORY THAT INCLUDES RADICAL NECK DISSECTION AND RADIATION TO THE RIGHT NECK. THE PATIENT WAS NOTED TO HAVE GREATER THAN 80% STENOSIS IN THE RIGHT INTERNAL CAROTID ARTERY. THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY. A JB 1 CATHETER WAS USED TO ACCESS THE ORIGIN OF THE COMMON CAROTID ARTERY, ARTERIOGRAM WAS PERFORMED IN MULTIPLE VIEWS WHICH CONFIRMED A HIGH-GRADE STENOSIS AT THE ORIGIN OF THE INTERNAL CAROTID ARTERY AND A SECOND STENOSIS OF AT LEAST 85% APPROXIMATELY 2 CM BEYOND THE ORIGIN, THE REMAINING COMMON CAROTID, INTERNAL, AND EXTERNAL CAROTID ARTERIES ARE WIDELY PATENT. THIS LESION WAS FELT TO BE SIGNIFICANT ENOUGH FOR PLACEMENT OF A CAROTID STENT. THE PATIENT WAS GIVEN 2000 UNITS OF HEPARIN PRIOR TO ACCESSING THE ORIGIN OF THE COMMON CAROTID ARTERY. SHE WAS GIVEN AN ADDITIONAL 3,000 UNITS OF HEPARIN PRIOR TO PLACING THE SHEATH. A WHOLEY WIRE WAS LEFT IN THE COMMON CAROTID ARTERY. THE CATHETER AND SHEATH WERE REMOVED AND A 90 CM SHUTTLE SHEATH PASSED INTO THE COMMON CAROTID ARTERY. A SELECTIVE ARTERIOGRAM WAS PERFORMED. THIS SHOWED PATENT COMMON, INTERNAL, AND EXTERNAL CAROTIDS WITH A HIGH-GRADE STENOSIS AT THE ORIGIN. THERE IS NOTED SIGNIFICANT CALCIFIC PLAQUE. THE EMBOLIC PROTECTION DEVICE WAS PASSED THROUGH THIS SHEATH AND BEYOND THE AREA OF STENOSIS INTO THE DISTAL INTERNAL CAROTID ARTERY AND DEPLOYED WITHOUT DIFFICULTY. DUE TO THE SIGNIFICANT NARROWING WITHIN THE PROXIMAL INTERNAL CAROTID ARTERY, A 4X20 AVIATOR BALLOON WAS USED TO PRE-DILATE THE LESION. THE PATIENT TOLERATED THIS WELL. POST ARTERIOGRAM SHOWED EVIDENCE OF SOME SPASM WITHIN THE INTERNAL CAROTID ARTERY, NO SIGNIFICANT THROMBUS OR FILLING DEFECTS WERE NOTED WITHIN THE CAROTID ARTERY.

    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 14057162

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R