BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE SDS SELF EXPANDING

    MDR report key: 3979078 · Received August 5, 2014

    Report

    Report Number
    9616099-2014-00510
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    November 1, 2012
    Report Date
    July 11, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K012993
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2014-00510 AND 1016427-2014-00095. COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY BALI ET AL CONCERTINA EFFECT DURING CAROTID ARTERY STENTING: REPORT OF A RARE PHENOMENON AND ITS MANAGEMENT ISSUES IN THIS VASCULAR TERRITORITY, NEUROLOGY (B)(4) 60 (2012) 652-653; A (B)(6) MALE WITH SYMPTOMATIC 70% STENOSIS OF RIGHT ICA, RECURRENT EPISODES OF RIGHT RETINAL TRANSIENT ISCHEMIC ATTACKS (TIAS), WAS TAKEN UP FOR CAS. DEPLOYMENT OF A 6-MM ANGIOGUARD XP FILTER DEVICE RESULTED IN APPEARANCE OF MULTIPLE NARROWINGS JUST DISTAL TO THE STENOTIC SEGMENT OF THE ICA. AFTER DIRECT STENTING WITH A 9 × 40 MM PRECISE RX NITINOL SELF-EXPANDING CAROTID STENT, A SEVERE STENOSIS WAS NOTED AT THE DISTAL EDGE OF THE DEPLOYED STENT, WHICH PERSISTED DESPITE GIVING INTRAARTERIAL NITROGLYCERINE. ALTHOUGH THE PATIENT REMAINED ASYMPTOMATIC, IT WAS DECIDED TO RETRIEVE THE DISTAL PROTECTION DEVICE (DPD) AS A LAST MEASURE TO RELIEVE THE SUSPECTED CONCERTINA EFFECT. EVEN AFTER REMOVAL OF THE DPD THE STENOSIS PERSISTED AND WE DECIDED TO DEPLOY ANOTHER STENT (8 × 30 MM PRECISE RX) TO TAKE CARE OF THIS IATROGENIC LESION. THERE WERE NO FURTHER COMPLICATIONS FOLLOWING DEPLOYMENT OF THE SECOND STENT AND THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELETS. THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE ,IT WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. AS STATED IN THE LITERATURE ARTICLE, THE ¿CONCERTINA OR ACCORDION EFFECT IS THE APPEARANCE OF PSEUDOLESIONS THAT APPEAR IN A TORTUOUS VESSEL WHEN IT IS STRAIGHTENED BY A GUIDE WIRE OR A CATHETER.¿ WITH THE PHYSICAL MANIPULATION OF A DISEASED VESSEL, SUCH AS WITH THE PLACEMENT OF DISTAL PROTECTION DEVICE AND STENT PLACEMENT, VESSEL COMPLICATIONS CAN BE ANTICIPATED BASED ON USER TECHNIQUE. WHILE THE CONCERTINA/ACCORDION EFFECT HAS BEEN DESCRIBED AS A RARE PHENOMENON WHEN RELATED TO PERIPHERAL VASCULAR MANIPULATIONS, SUCH CONDITIONS SHOULD BE MONITORED AND TREATED ACCORDINGLY. AS DESCRIBED IN THE ARTICLE, THE REASON FOR THIS PHENOMENON IS UNKNOWN; HOWEVER IT COULD POSSIBLY BE RELATED TO THE LENGTH OF THE STENT IMPLANTED OR THE USER HANDLING TECHNIQUE OF THE DEVICES. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. HOWEVER, THE INFORMATION PROVIDED DOES NOT INDICATE THAT THE EVENT IS A DESIGN OR MANUFACTURING RELATED ISSUE; THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: AS REPORTED BY THE AFFILIATE, THE CONCERTINA EFFECT "IS RELATED TO LARGER SIZE STENT PLACED IN A NARROWED ARTERY WHICH LEADS TO THIS SYMPTOM. I HAD DISCUSSED WITH THE OPERATOR AND THEY ACCEPTED THAT IT IS A SELECTION OF WRONG SIZE STENT FROM THERE SIDE AND NOT A PRODUCT COMPLAIN." THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2014-00510 AND 1016427-2014-00095. UPDATED COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY BALI ET AL CONCERTINA EFFECT DURING CAROTID ARTERY STENTING: REPORT OF A RARE PHENOMENON AND ITS MANAGEMENT ISSUES IN THIS VASCULAR TERRITORITY, NEUROLOGY (B)(4) 60 (2012) 652-653; A (B)(6) MALE WITH SYMPTOMATIC 70% STENOSIS OF RIGHT ICA, RECURRENT EPISODES OF RIGHT RETINAL TRANSIENT ISCHEMIC ATTACKS (TIAS), WAS TAKEN UP FOR CAS. DEPLOYMENT OF A 6-MM ANGIOGUARD XP FILTER DEVICE RESULTED IN APPEARANCE OF MULTIPLE NARROWINGS JUST DISTAL TO THE STENOTIC SEGMENT OF THE ICA. AFTER DIRECT STENTING WITH A 9 × 40 MM PRECISE RX NITINOL SELF-EXPANDING CAROTID STENT, A SEVERE STENOSIS WAS NOTED AT THE DISTAL EDGE OF THE DEPLOYED STENT, WHICH PERSISTED DESPITE GIVING INTRAARTERIAL NITROGLYCERINE. ALTHOUGH THE PATIENT REMAINED ASYMPTOMATIC, IT WAS DECIDED TO RETRIEVE THE DISTAL PROTECTION DEVICE (DPD) AS A LAST MEASURE TO RELIEVE THE SUSPECTED CONCERTINA EFFECT. EVEN AFTER REMOVAL OF THE DPD THE STENOSIS PERSISTED AND WE DECIDED TO DEPLOY ANOTHER STENT (8 × 30 MM PRECISE RX) TO TAKE CARE OF THIS IATROGENIC LESION. THERE WERE NO FURTHER COMPLICATIONS FOLLOWING DEPLOYMENT OF THE SECOND STENT AND THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELETS. AS REPORTED BY THE AFFILIATE, THE CONCERTINA EFFECT "IS RELATED TO LARGER SIZE STENT PLACED IN A NARROWED ARTERY WHICH LEADS TO THIS SYMPTOM. I HAD DISCUSSED WITH THE OPERATOR AND THEY ACCEPTED THAT IT IS A SELECTION OF WRONG SIZE STENT FROM THERE SIDE AND NOT A PRODUCT COMPLAIN." (B)(4)- THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. (B)(4) ¿ THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, IT WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. AS STATED IN THE LITERATURE ARTICLE, THE ¿CONCERTINA OR ACCORDION EFFECT IS THE APPEARANCE OF PSEUDOLESIONS THAT APPEAR IN A TORTUOUS VESSEL WHEN IT IS STRAIGHTENED BY A GUIDE WIRE OR A CATHETER.¿ WITH THE PHYSICAL MANIPULATION OF A DISEASED VESSEL, SUCH AS WITH THE PLACEMENT OF DISTAL PROTECTION DEVICE AND STENT PLACEMENT, VESSEL COMPLICATIONS CAN BE ANTICIPATED BASED ON USER TECHNIQUE. WHILE THE CONCERTINA/ACCORDION EFFECT HAS BEEN DESCRIBED AS A RARE PHENOMENON WHEN RELATED TO PERIPHERAL VASCULAR MANIPULATIONS, SUCH CONDITIONS SHOULD BE MONITORED AND TREATED ACCORDINGLY. AS DESCRIBED IN THE ARTICLE, THE REASON FOR THIS PHENOMENON IS UNKNOWN; HOWEVER IT COULD POSSIBLY BE RELATED TO THE LENGTH OF THE STENT IMPLANTED OR THE USER HANDLING TECHNIQUE OF THE DEVICES. AS PROVIDED BY THE AFFILIATE, THE OPERATOR BELIEVES THE EVENT WAS DUE TO CHOOSING THE WRONG SIZE OF THE STENT AND HOW IT WAS LARGER THAN THE USED STENT SHOULD HAVE BEEN. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. HOWEVER, THE INFORMATION PROVIDED DOES NOT INDICATE THAT THE EVENT IS A DESIGN OR MANUFACTURING RELATED ISSUE; THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, IT IS NOT AVAILABLE FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: BALI ET AL (2012). CONCERTINA EFFECT DURING CAROTID ARTERY STENTING: REPORT OF A RARE PHENOMENON AND ITS MANAGEMENT ISSUES IN THIS VASCULAR TERRORITY. NEUROLOGY INDIA 60, 652-653. CONCOMITANT MEDICATIONS: NITROGLYCERIN WAS GIVEN DURING THE PROCEDURE. DUAL ANTIPLATELETS WERE GIVEN FOR DISCHARGE. CONCOMITANT DEVICES: UNKNOWN ANGIOGUARD DEVICE, AND AN UNKNOWN 40MM STENT. THE CATALOG CODE PROVIDED (NXXXSB), REPRESENTS AN UNKNOWN PRECISE STENT. THE CATALOG AND LOT NUMBERS FOR THE ACTUAL PRODUCT USED IN THE PROCEDURE ARE UNKNOWN. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2014-00510 AND 1016427-2014-00095.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY BALI ET AL CONCERTINA EFFECT DURING CAROTID ARTERY STENTING: REPORT OF A RARE PHENOMENON AND ITS MANAGEMENT ISSUES IN THIS VASCULAR "TERRORITY", NEUROLOGY INDIA 60 (2012) 652-653; AN 84-YEAR-OLD MALE WITH SYMPTOMATIC 70% STENOSIS OF RIGHT ICA, RECURRENT EPISODES OF RIGHT RETINAL TRANSIENT ISCHEMIC ATTACKS (TIAS), WAS TAKEN UP FOR CAS. DEPLOYMENT OF A 6-MM ANGIOGUARD XP FILTER DEVICE RESULTED IN APPEARANCE OF MULTIPLE NARROWINGS JUST DISTAL TO THE STENOTIC SEGMENT OF THE ICA. AFTER DIRECT STENTING WITH A 9 × 40 MM PRECISE RX NITINOL SELF-EXPANDING CAROTID STENT, A SEVERE STENOSIS WAS NOTED AT THE DISTAL EDGE OF THE DEPLOYED STENT, WHICH PERSISTED DESPITE GIVING INTRAARTERIAL NITROGLYCERINE. ALTHOUGH THE PATIENT REMAINED ASYMPTOMATIC, IT WAS DECIDED TO RETRIEVE THE DISTAL PROTECTION DEVICE (DPD) AS A LAST MEASURE TO RELIEVE THE SUSPECTED CONCERTINA EFFECT. EVEN AFTER REMOVAL OF THE DPD THE STENOSIS PERSISTED AND WE DECIDED TO DEPLOY ANOTHER STENT (8 × 30 MM PRECISE RX) TO TAKE CARE OF THIS IATROGENIC LESION. THERE WERE NO FURTHER COMPLICATIONS FOLLOWING DEPLOYMENT OF THE SECOND STENT AND THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457464 PRECISE SDS SELF EXPANDING SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening| R