BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2232067 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06109
    Event Type
    Death
    Date Received
    September 1, 2011
    Date of Event
    August 6, 2011
    Report Date
    August 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A CINE OF THE PROCEDURE WAS RECEIVED AND REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. THE REVIEWER NOTED TARGET LESION IS IN THE MID TO PROXIMAL CIRCUMFLEX (CX). GUIDE WIRES ARE PLACED IN A LARGE MARGINAL BRANCH AND THE MAIN BRANCH CX. MULTIPLE BALLOON INFLATIONS ARE SEEN MID TO PROXIMAL. THE MID CX IS STENTED. THERE IS A SECOND STENT DEPLOYED PROXIMAL AND OVERLAPPED WITH THE FIRST STENT. THERE IS A PARTIALLY DEFLATED STENT DELIVERY SYSTEM (SDS), WHICH HAS BEEN MOVED SLIGHTLY MORE PROXIMALLY TO ITS ORIGINAL POSITION. CONTRAST CAN BE SEEN IN THE PROXIMAL AND DISTAL TAPERS OF THE BALLOON. THE GUIDING CATHETER HAS MOVED FURTHER DOWN AND THE PROXIMAL BALLOON TAPER IS INTUBATED IN THE GUIDING CATHETER. CONTRAST IS INJECTED AND OCCLUSION OF THE CX IS DEMONSTRATED. SEVERAL IMAGES SHOW THE DISTAL HYPOTUBE AT THE GUIDE WIRE EXIT NOTCH. JUST DISTAL TO THE HYPOTUBE THE DISTAL SHAFT IS SEPARATED. THE REVIEWER CONCLUDED THAT THERE WAS LIKELY RESISTANCE POST STENT DEPLOYMENT WITH A PROBABLE SHAFT SEPARATION RESULTING IN THE DISTAL SHAFT SECTION LEFT BEHIND. AN ABBOTT VASCULAR QUALITY ENGINEER WAS ABLE TO ANALYZE THE SEPARATED XIENCE V SDS AT THE ACCOUNT. THE ENGINEER NOTED THE UNIT WAS PROVIDED IN TWO SECTIONS, A DISTAL SECTION AND A PROXIMAL SECTION. THE DISTAL SECTION WAS COMPRISED OF THE TIP, BALLOON, DISTAL OUTER MEMBER, INNER MEMBER AND A PORTION OF THE MID SHAFT. THE CATHETER WAS COVERED WITH DRIED BLOOD, CONSISTENT WITH ADVANCEMENT IN THE PATIENT ANATOMY. THE PROXIMAL END CONTAINED THE RX NOTCH, A PORTION OF THE MID SHAFT AND THE PROXIMAL HYPOTUBE WITH THE SINGLE ARM ATTACHMENT. THE BALLOON WAS INSPECTED AND IT APPEARED TO CONTAIN A SMALL AMOUNT OF CONTRAST/BLOOD INSIDE THE DISTAL AND PROXIMAL TAPERS AS WELL AS WITHIN THE WORKING LENGTH FOLDS. A CLOSER INSPECTION OF THE DISTAL END OF THE PROXIMAL SECTION OF THE UNIT REVEALED A STRETCHED PORTION OF THE MIDSHAFT AT THE SEPARATION LOCATION WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). AN INSPECTION OF THE PROXIMAL END OF THE DISTAL SECTION ALSO REVEALED A STRETCHED PORTION OF MIDSHAFT MATERIAL AT A LOCATION. THE REST OF THE BODY OF THE CATHETER WAS INSPECTED FOR ADDITIONAL DAMAGE. NO DAMAGE WAS FOUND ON THE JUNCTION/NOTCH, THE HYPOTUBE OR THE DISTAL OUTER MEMBER PORTIONS OF THE CATHETER. THE ENGINEER CONCLUDED THAT AFTER THESE OBSERVATIONS, THERE WERE NO INDICATIONS OF ANY MANUFACTURING ISSUES WITH THE DEVICE. THE SEPARATION AREA SHOWED A STRETCHED PORTION WHICH COULD BE A SIGN OF EXCESSIVE TENSION APPLIED TO THIS SECTION. FACTORS THAT CAN CONTRIBUTE TO SHAFT SEPARATIONS INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, HANDLING DURING PREPARATION, PRODUCT PLACEMENT TECHNIQUE, FRACTURE/KINKED SHAFT, OR WEAK SEALS. IN THIS CASE, IT IS POSSIBLE THE BALLOON WAS NOT COMPLETELY DEFLATED PRIOR TO THE REMOVAL ATTEMPTS, AS NOTED IN THE CINE REVIEW. ADDITIONALLY, IF THE BALLOON WAS NOT COMPLETELY DEFLATED PRIOR TO REMOVAL, THIS WOULD CONTRIBUTE TO RESISTANCE DURING RETRACTION OF THE SDS. IF FORCE WAS APPLIED IN THE ATTEMPTS TO REMOVE THE SDS, THIS WOULD CONTRIBUTE TO THE SHAFT SEPARATION; HOWEVER THIS COULD NOT BE CONFIRMED. BRADYCARDIA, EMBOLISM, HYPOTENSION, ISCHEMIA, VENTRICULAR TACHYCARDIA, AND DEATH ARE LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS OF CORONARY STENTING. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICE CANNOT BE DETERMINED. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT REVEALED NO ASSOCIATED NONCONFORMING MATERIAL RECORDS, INDICATING ALL LOT RELEASE TESTING MET SPECIFICATION. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO SIMILAR INCIDENTS REPORTED FOR SHAFT SEPARATIONS. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. TO ENSURE THIS IS NOT A RESULT OF A MANUFACTURING DEFICIENCY, ALL PRODUCTS ARE VISUALLY INSPECTED FOR DAMAGE DURING THE MANUFACTURING PROCESS, INCLUDING AT THE POINT THE PRODUCT IS PLACED IN THE COIL DISPENSER.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE PHYSICIAN TRIED TO SNARE THE DELIVERY CATHETER WITH A 1.25 MM BALLOON AND A BUDDY GUIDE WIRE, DELIVERY OF A GUIDELINER AND A SNARE DEVICE WITH NO SUCCESS. THE REMAINDER OF THE DISTAL CATHETER REMAINED IN THE PATIENT. THE PATIENT BECAME EXTREMELY UNSTABLE AND WAS BRADYCARDIC AND HYPOTENSIVE NOT RESPONSIVE TO MULTIPLE DOSES OF ATROPINE. A 5FR BALLOON TIPPED TEMPORARY PACER WAS PLACED AND THE PATIENT WAS GIVEN IV FLUIDS AND DOPAMINE. THE PATIENT WENT INTO CARDIAC ARREST AND RESPIRATORY FAILURE REQUIRING CARDIOPULMONARY RESUSCITATION AND INTUBATION. THE PATIENT DEVELOPED VENTRICULAR TACHYCARDIA (VT) AND AN IV OF AMIODARONE WAS ADMINISTERED AND THE VT REQUIRED DEFIBRILLATION. HOWEVER, THE PATIENT EXPIRED ON THE CATH LAB TABLE. NO ADDITIONAL INFORMATION WAS PROVIDED. GUIDE WIRE: PROWATER FLEX X2. GUIDE CATH: 6 FR EBU 4.5. SHEATH: 6FR. STENT: XIENCE 2.75 X 18 MM. THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ARRIVED AT THE CATH LAB ON (B)(6) 2011, WITH A NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION, TROPONIN LEVEL 0.9, ANTEROLATERAL T WAVE INVERSION ON ELECTROCARDIOGRAM AND RECURRENT PAIN. A 6 FRENCH EBU 4.5 GUIDING CATHETER WAS USED. THERE WAS DISEASED AREA IN THE PROXIMAL DOMINANT CIRCUMFLEX 95%, AND 70 AND 99% DISEASE IN THE MID DOMINANT LEFT CIRCUMFLEX. THERE WAS MODERATE TORTUOSITY IN CIRCUMFLEX ARTERY. TWO PROWATER FLEX GUIDE WIRES WERE USED, ONE IN THE LOWER MARGINAL BRANCH OF THE LEFT CIRCUMFLEX AND ONE IN THE LEFT POSTERIOR LATERAL BRANCH. A TREK 3.0 X 15 BALLOON CATHETER WAS USED TO PREDILATE BOTH LESIONS. A XIENCE 2.75X18 WAS DEPLOYED AT 10 ATMOSPHERES (ATM) AND PLACED IN MID CIRCUMFLEX; BOTH WIRES REMAINED IN THE VESSEL. THE XIENCE DELIVERY SYSTEM WAS REMOVED WITHOUT COMPLICATION. A 3.5X28 XIENCE WAS PLACED IN PROXIMAL CIRCUMFLEX AT 10 ATM; BOTH WIRES REMAINED IN THE VESSEL; THE STENTS WERE OVERLAPPING. THE BALLOON DEFLATED PER THE PHYSICIAN AND UPON REMOVAL HE NOTICED HE HAD ONLY A PARTIAL DELIVERY SYSTEM. THE PHYSICIAN'S PRACTICE IS TO INFLATE THE STENT DELIVERY BALLOON AND FOR DEFLATION, THE INDEFLATOR IS USED AND THEN A 10CC SYRINGE IS ALSO USED TO COMPLETE DEFLATION. SO NEGATIVE WAS PULLED TWICE. UPON REMOVAL, NO DIFFERENCE OR RESISTANCE WAS FELT. THIS IS HIS TYPICAL PRACTICE FOR LONG BALLOON LENGTHS. THE NEXT SHOT, HE INITIALLY SAW SLOW FLOW AND NICARDIPINE WAS ADMINISTERED. IN THE NEXT PICTURE HE NOTICED THE BALLOON DELIVERY PORTION FROM THE GUIDE WIRE EXIT PORT TO THE DISTAL PORTION WAS SEVERED [SEPARATED] AND LODGED INTO THE CIRCUMFLEX AND LEFT MAIN. THE PATIENT HAD NO REFLOW OF THE VESSEL AND STARTED TO DECOMPENSATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1021841

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death