BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE SDS SELF EXPANDING

    MDR report key: 3909082 · Received July 2, 2014

    Report

    Report Number
    9616099-2014-00442
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    November 1, 2002
    Report Date
    June 11, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K012993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION CONTINUED: TO A POSITION PROXIMAL TO THE CAROTID LESION. QUANTITATIVE CAROTID ANGIOGRAPHY WAS THEN PERFORMED USING THE PHILIPS INTEGRIS V3000 (PHILIPS MEDICAL SYSTEMS, (B)(4)). INITIALLY, A 0.014-IN STEERABLE CORONARY GUIDE WIRE IS USED TO CROSS THE LESION AND THEN EXCHANGED FOR A 0.014-IN EXTRA-SUPPORT GUIDE WIRE (ATW WIRE, CORDIS CORP., JOHNSON & JOHNSON, (B)(4)). PREDILATATION WAS PERFORMED USING A LOW-PROFILE 4.0-MM CORONARY BALLOON, WITH PROLONGED DILATATION (FOR 2 MINUTES IF TOLERATED) FOLLOWED BY SLOW DEFLATION. A SELFEXPANDING STENT IS THEN USED (6F PRECISE SMART STENT, CORDIS CORP., JOHNSON & JOHNSON, (B)(4)). POSTSTENT DILATATION IS DONE IF MORE THAN 20% RESIDUAL STENOSIS IS NOTED, USING A BALLOON SIZE NOT EXCEEDING THE SIZE OF THE DISTAL NONTAPERING INTERNAL CAROTID. CONCOMITANT PRODUCTS: 6-FRENCH ARTERIAL SHEATH (SHUTTLE; COOK INC., (B)(4)); 5-FRENCH CAROTID DIAGNOSTIC CATHETER (MANI; CORDIS CORP., JOHNSON & JOHNSON, (B)(4)); 0.038-IN TERUMO GLIDE WIRE (BOSTON SCIENTIFIC, (B)(4)); PHILIPS INTEGRIS V3000 (PHILIPS MEDICAL SYSTEMS, (B)(4)); 0.014-IN EXTRA-SUPPORT GUIDE WIRE (ATW WIRE, CORDIS CORP., JOHNSON & JOHNSON, (B)(4)). PRE-PROCEDURE: ALL PATIENTS RECEIVE ASPIRIN, 325 MG/D, AND EITHER CLOPIDOGREL (PLAVIX), 75 MG/D, OR TICLOPIDINE, 250 MG TWICE A DAY, FOR AT LEAST 3 DAYS (OR FOR 5¿7 DAYS IN PATIENTS WITH TRANSIENT ISCHEMIC ATTACKS, WHEN FEASIBLE) PRIOR TO CAS AND THE MORNING OF THE PROCEDURE. INTRA PROCEDURE MEDICATIONS INCLUDED HEPARIN AND ATROPINE SULFATE. POST PROCEDURE: ALL PATIENTS ARE TREATED WITH ASPIRIN, 325 MG/D, INDEFINITELY AND PLAVIX, 75 MG/D, FOR 4 WEEKS. PLEASE NOTE THAT THIS EVENT WAS IDENTIFIED DURING A (B)(4) LITERATURE SEARCH, THE CITATION OF THE PUBLICATION IS AS FOLLOWS: SHAWL ET AL CAROTID ARTERY STENTING: ACUTE AND LONG-TERM RESULTS, CURR OPIN CARDIOL. 17 (2002) 671-676; PLEASE NOTE THAT THIS REPORT REPRESENTS NOTIFICATION OF 9 PATIENTS ASSOCIATED WITH 7 MINOR STROKES AND 2 MAJOR STROKES FOR WHOM SPECIFIC PATIENT DETAILS ARE NOT AVAILABLE (AGE, GENDER, MEDICAL HISTORY AND DEVICE INFORMATION). THIS IS ONE OF THREE REPORTS ASSOCIATED WITH THE ADVERSE EVENTS NOTED IN THE EVENT DESCRIPTION AND WERE SUBMITTED UNDER MANUFACTURING REPORT NUMBERS 9616099-2014-00442, 9616099-2014-00443 AND 9616099-2014-00444.

    Additional Manufacturer Narrative · 1

    AS NOTED IN THE PUBLICATION BY SHAWL ET AL CAROTID ARTERY STENTING: ACUTE AND LONG-TERM RESULTS, CURR OPIN CARDIOL. 17 (2002) 671-676; TWO MAJOR STROKES AND SEVEN MINOR STROKES OCCURRED DURING HOSPITALIZATION OR IN THE 30 DAYS FOLLOWING CAROTID ARTERY STENTING (CAS) WITH A PRECISE STENT. THREE PATIENTS HAD MINOR STROKES AT THE LATE FOLLOW-UP PERIOD AFTER PRECISE STENT PLACEMENT. EIGHT PATIENTS HAD ASYMPTOMATIC RESTENOSIS (STENOSIS GREATER THAN OR EQUAL TO 60%) AND ALL WERE SUCCESSFULLY REDILATED. MINOR STROKE WAS DEFINED AS A NEW NEUROLOGIC DEFICIT THAT EITHER RESOLVES COMPLETELY OR RETURNS TO BASELINE WITHIN 30 DAYS OR THAT CHANGES THE NIH STROKE SCALE BY TWO OR THREE POINTS. BY DEFINITION, MINOR STROKE IS A NONDISABLING NEUROLOGIC EVENT. MAJOR STROKE WAS CONSIDERED A NEW NEUROLOGIC DEFICIT THAT PERSISTS AFTER 30 DAYS AND THAT CHANGES THE NIH STROKE SCALE BY FOUR POINTS OR MORE. WITH RESPECT TO CAROTID ANATOMY, 84% OF LESIONS WERE ECCENTRIC, 35% HAD CALCIUM PRESENT ON FLUOROSCOPY, 56% WERE OF MODERATE-TO-SEVERE TORTUOSITY, AND 19% WERE SURGICALLY INACCESSIBLE BECAUSE OF THEIR LOCATION ABOVE THE ¿BLESDALE LINE¿ OR AT THE ORIGIN OF THE COMMON CAROTID. THIRTY-TWO PATIENTS (11%) WITH RECENT CVA WERE ANTICOAGULATED WITH WARFARIN PRIOR TO THE PROCEDURE BECAUSE ANGIOGRAPHY SUGGESTED THE PRESENCE OF THROMBUS. HEPARIN WAS GIVEN INTRAVENOUSLY, BEGINNING WITH A BOLUS DOSE OF 5000 TO 7000 IU, AS NECESSARY TO MAINTAIN AN ACTIVATED CLOTTING TIME OF 225 TO 270 SECONDS. A 5-FRENCH CAROTID DIAGNOSTIC CATHETER ((B)(4); CORDIS CORP., JOHNSON & JOHNSON, (B)(4)) WAS USED TO ENGAGE THE CAROTID ARTERY OVER A 0.038-IN TERUMO GLIDE WIRE (BOSTON SCIENTIFIC, (B)(4)). THE CATHETER IS ADVANCED INTO A BRANCH OF THE EXTERNAL CAROTID ARTERY. THIS SERVED AS AN EXCHANGE CATHETER FOR PLACEMENT OF A 0.038-IN AMPLATZ EXTRA STIFF GUIDE WIRE (COOK INC., (B)(4)). AFTER REMOVAL OF THE DIAGNOSTIC CATHETER, A 6-FRENCH SHEATH WAS ADVANCED OVER THE EXTRA STIFF EXCHANGE WIRE TO A POSITION PROXIMAL TO THE CAROTID LESION. QUANTITATIVE CAROTID ANGIOGRAPHY WAS THEN PERFORMED USING THE PHILIPS INTEGRIS V3000 (PHILIPS MEDICAL SYSTEMS, (B)(4)). INITIALLY, A 0.014-IN STEERABLE CORONARY GUIDE WIRE IS USED TO CROSS THE LESION AND THEN EXCHANGED FOR A 0.014-IN EXTRA-SUPPORT GUIDE WIRE (ATW WIRE, CORDIS CORP., JOHNSON & JOHNSON, (B)(4)). PREDILATATION WAS PERFORMED USING A LOW-PROFILE 4.0-MM CORONARY BALLOON, WITH PROLONGED DILATATION (FOR 2 MINUTES IF TOLERATED) FOLLOWED BY SLOW DEFLATION. A SELF EXPANDING STENT IS THEN USED (6F PRECISE SMART STENT, CORDIS CORP., JOHNSON & JOHNSON, (B)(4)). POSTSTENT DILATATION IS DONE IF MORE THAN 20% RESIDUAL STENOSIS IS NOTED, USING A BALLOON SIZE NOT EXCEEDING THE SIZE OF THE DISTAL NON TAPERING INTERNAL CAROTID. THE STENTS REMAIN IMPLANTED AND ARE THUS UNAVAILABLE FOR ANALYSIS. THERE IS NO STERILE LOT NUMBER AVAILABLE; THEREFORE A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED. CEREBROVASCULAR ACCIDENT IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY AND IS LISTED IN THE IFU AS SUCH. IT CAN BE DEFINED AS A CEREBROVASCULAR DISORDER CAUSED BY DEPRIVATION OF BLOOD FLOW TO AN AREA OF THE BRAIN, GENERALLY AS A RESULT OF THROMBOSIS, EMBOLISM, OR REDUCED BLOOD PRESSURE. THE ACT OF STENT EXPANSION OR POST-DILATATION, TO OPTIMALLY OPPOSE A CAROTID STENT TO THE VESSEL WALL, TEMPORARILY OBSTRUCTS BLOOD FLOW TO THE CEREBRAL ARTERIES (ISCHEMIC PROCESS). THE PHYSICAL MANIPULATION OF THE CAROTID ARTERIES PRODUCES THE RISK OF DISLODGEMENT OF DEBRIS THAT MAY TRAVEL UPSTREAM TO THE CEREBRAL ARTERIES POTENTIALLY DISRUPTING PERFUSION. THIS ACT, INHERENT TO THE PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A BLOOD VESSEL THAT IS NOT BLOCKED, BUT IS EXTREMELY NARROWED, CAN ALSO CAUSE AN ISCHEMIC STROKE. THE BLOCKED OR NARROWED ARTERIES DEPRIVE BRAIN CELLS OF OXYGEN AND NUTRIENTS, LEADING TO NERVE CELL DEATH. 80% OF ALL STROKES ARE ISCHEMIC. DURING ISCHEMIC STROKE, DIMINISHED BLOOD FLOW INITIATES A SERIES OF EVENTS (CALLED ISCHEMIC CASCADE) THAT MAY RESULT IN ADDITIONAL, DELAYED DAMAGE TO BRAIN CELLS. EARLY MEDICAL INTERVENTION CAN HALT THIS PROCESS AND REDUCE THE RISK FOR IRREVERSIBLE COMPLICATIONS. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENTS. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. IN-STENT RESTENOSIS (ISR) IS ASSOCIATED WITH THE PROGRESSION OF ATHEROSCLEROTIC DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND DOES NOT REPRESENT A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS, IT IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. VESSEL OCCLUSION, RESTENOSIS, INTIMAL HYPERPLASIA OR RECURRENT STRICTURES ARE WELL KNOWN DOCUMENTED POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. PLEASE NOTE THAT THIS EVENT WAS IDENTIFIED DURING A MONTHLY LITERATURE SEARCH, THE CITATION OF THE PUBLICATION IS AS FOLLOWS: SHAWL ET AL CAROTID ARTERY STENTING: ACUTE AND LONG-TERM RESULTS, CURR OPIN CARDIOL. 17 (2002) 671-676. PLEASE NOTE THAT THIS REPORT REPRESENTS NOTIFICATION OF 9 PATIENTS ASSOCIATED WITH 7 MINOR STROKES AND 2 MAJOR STROKES FOR WHOM SPECIFIC PATIENT DETAILS ARE NOT AVAILABLE (AGE, GENDER, MEDICAL HISTORY AND DEVICE INFORMATION). THIS IS ONE OF THREE REPORTS ASSOCIATED WITH THE ADVERSE EVENTS NOTED IN THE EVENT DESCRIPTION AND WERE SUBMITTED UNDER MANUFACTURING REPORT NUMBERS 9616099-2014-00442, 9616099-2014-00443 AND 9616099-2014-00444.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY SHAWL ET AL CAROTID ARTERY STENTING: ACUTE AND LONG-TERM RESULTS, CURR OPIN CARDIOL. 17 (2002) 671-676; TWO MAJOR STROKES AND SEVEN MINOR STROKES OCCURRED DURING HOSPITALIZATION OR IN THE 30 DAYS FOLLOWING CAROTID ARTERY STENTING (CAS) WITH A PRECISE STENT. THREE PATIENTS HAD MINOR STROKES AT THE LATE FOLLOW-UP PERIOD AFTER PRECISE STENT PLACEMENT. 8 PATIENTS HAD ASYMPTOMATIC RESTENOSIS (STENOSIS GREATER THAN OR EQUAL TO 60%) AND ALL WERE SUCCESSFULLY REDILATED. MINOR STROKE WAS DEFINED AS A NEW NEUROLOGIC DEFICIT THAT EITHER RESOLVES COMPLETELY OR RETURNS TO BASELINE WITHIN 30 DAYS OR THAT CHANGES THE NIH STROKE SCALE BY TWO OR THREE POINTS. BY DEFINITION, MINOR STROKE IS A NONDISABLING NEUROLOGIC EVENT. MAJOR STROKE WAS CONSIDERED A NEW NEUROLOGIC DEFICIT THAT PERSISTS AFTER 30 DAYS AND THAT CHANGES THE NIH STROKE SCALE BY FOUR POINTS OR MORE. WITH RESPECT TO CAROTID ANATOMY, 84% OF LESIONS WERE ECCENTRIC, 35% HAD CALCIUM PRESENT ON FLUOROSCOPY, 56% WERE OF MODERATE-TO-SEVERE TORTUOSITY, AND 19% WERE SURGICALLY INACCESSIBLE BECAUSE OF THEIR LOCATION ABOVE THE ¿BLESDALE LINE¿ OR AT THE ORIGIN OF THE COMMON CAROTID. THIRTY-TWO PATIENTS (11%) WITH RECENT CVA WERE ANTICOAGULATED WITH WARFARIN PRIOR TO THE PROCEDURE BECAUSE ANGIOGRAPHY SUGGESTED THE PRESENCE OF THROMBUS. HEPARIN WAS GIVEN INTRAVENOUSLY, BEGINNINGWITH A BOLUS DOSE OF 5000 TO 7000 IU, AS NECESSARY TO MAINTAIN AN ACTIVATED CLOTTING TIME OF 225 TO 270 SECONDS. A 5-FRENCH CAROTID DIAGNOSTIC CATHETER (MANI; CORDIS CORP., JOHNSON & JOHNSON, (B)(4)) WAS USED TO ENGAGE THE CAROTID ARTERY OVER A 0.038-IN TERUMO GLIDE WIRE (BOSTON SCIENTIFIC, (B)(4)). THE CATHETER IS ADVANCED INTO A BRANCH OF THE EXTERNAL CAROTID ARTERY. THIS SERVED AS AN EXCHANGE CATHETER FOR PLACEMENT OF A 0.038-IN AMPLATZ EXTRA STIFF GUIDE WIRE (COOK INC., (B)(4)). AFTER REMOVAL OF THE DIAGNOSTICCATHETER, A 6-FRENCH SHEATH WAS ADVANCED OVER THE EXTRA STIFF EXCHANGE WIRE...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387125 PRECISE SDS SELF EXPANDING SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1