BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 4130267 · Received September 30, 2014

    Report

    Report Number
    2024168-2014-06325
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CASE DESCRIPTION CONTINUED: THE OSTIUM WAS SEQUENTIALLY DILATED WITH 2 NC TREK BALLOONS (3.5X20 AND A 4.0X20 MM); HOWEVER, WAS STILL UNABLE TO CROSS WITH THE GRAFTMASTER STENT. A 3.0X26 MM GRAFTMASTER STENT WAS THEN ADVANCED INTO THE DISTAL LAD AND DEPLOYED AT 12 ATMOSPHERES. SINCE PROTAMINE HAD BEEN GIVEN, IT WAS NOTED THAT THE CX HAD BECOME THROMBOTICALLY OCCLUDED. A NON-ABBOTT GUIDE WIRE HAD BEEN LEFT IN THE CX THROUGHOUT THE CASE, SO AN ASPIRATION CATHETER WAS ADVANCED INTO THE CX. MULTIPLE RUNS OF ASPIRATION THROMBECTOMY WERE PERFORMED RESTORING FLOW TO THE CX. DUE TO THE MULTIPLE DILATATIONS NECESSARY TO ADVANCE THE GRAFTMASTER STENT THE OSTIUM OF THE CX HAD BECOME STENOSED, LIKELY DUE TO A PLAQUE SHIFT WITH A SMALL DISSECTION. THE OSTIUM OF THE CX WAS THEN STENTED IN OVERLAPPING FASHION INTO THE LEFT MAIN WITH A 4.0X12 MM XIENCE XPEDITION STENT AFTER WHICH POST-DILATATION WAS PERFORMED. AT THE END OF THE CASE, THE LAD REMAINED OCCLUDED PROXIMALLY AND THE CX AND RIGHT CORONARY ARTERY WERE PATENT. OF NOTE: THE PATIENT DEVELOPED CHEST PAIN AT SEVERAL POINTS THROUGHOUT THE CASE, INCLUDING BALLOON INFLATION IN THE LAD, PERFORATION OF THE LAD, AND THROMBOTIC OCCLUSION OF THE OSTIUM OF THE CX AND BECAME HEMODYNAMICALLY UNSTABLE AFTER THE PERFORATION OF THE LAD OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED. CONCOMITANT PRODUCT: STENTS: XIENCE XPEDITION (2.5X28, 3.0X28, 3.5X15, 3.5X18 MM), REINSERTION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ADDITIONAL DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT WAS REPORTED THE JOSTENT GRAFTMASTER WAS REINTRODUCED INTO THE PATIENT ANATOMY. THE GRAFTMASTER INSTRUCTION FOR USE STATES: AN UNEXPANDED STENT GRAFT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. AN UNEXPANDED STENT GRAFT SHOULD NOT BE REINTRODUCED INTO THE ARTERY ONCE IT HAS BEEN PULLED BACK INTO THE GUIDING CATHETER. SUBSEQUENT MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED, AS THE STENT GRAFT MAY BE DAMAGED WHEN RETRACTING THE UNDEPLOYED STENT GRAFT BACK INTO THE GUIDING CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESIONS LOCATED IN THE CIRCUMFLEX (CX) AND THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A LONG FIELDER GUIDE WIRE WAS ADVANCED INTO THE CX WITH AN OVER-THE-WIRE BALLOON FOR BACKUP. THE FIELDER GUIDE WIRE WAS REMOVED AS IT HAD CAUSED A DISSECTION. A NON-ABBOTT GUIDE WIRE WAS ADVANCED INTO THE DISTAL CX, AFTER WHICH CX WAS STENTED FROM DISTAL TO PROXIMAL WITH 3 XIENCE XPEDITION STENTS (2.5X28, 3.0X28, 3.5X15 MM). THE STENTS IN THE PROXIMAL AND MID CX WAS THEN POST-DILATED WITH AN NC TREK BALLOON. AT THIS POINT IT WAS DETERMINED THAT THE PROXIMAL EDGE OF THE DISSECTION WAS NOT STENTED; THEREFORE, A 3.5X18 MM XIENCE XPEDITION STENT WAS DEPLOYED PROXIMAL TO COVER THE EDGE OF THE DISSECTION. PRE-DILATATION WAS THEN PERFORMED ON THE LAD. THE LAD WAS STENTED WITH A 2.75X33 MM XIENCE XPEDITION STENT DISTALLY AND A 3.0X33 MM XIENCE XPEDITION STENT IN THE MID PORTION. AFTER DEPLOYMENT OF THE LAD STENTS, NO RE-FLOW WAS NOTED IN THE DISTAL VASCULAR BED FOR WHICH MEDICATIONS WERE ADMINISTERED. A LARGE TYPE 3 PERFORATION WAS OBSERVED IN THE DISTAL LAD. BALLOON INFLATIONS WERE PERFORMED TO ACHIEVE HEMOSTASIS. WHILE THE BALLOON WAS INFLATED IN THE LAD, PROTAMINE WAS GIVEN FOR HEPARIN REVERSAL. IV BLOOD TRANSFUSION WAS STARTED ALONG-WITH HEPARIN AND IV FLUIDS. BEDSIDE ECHOCARDIOGRAPHY CONFIRMED DEVELOPMENT OF A NEW PERICARDIAL EFFUSION SO A PERICARDIAL DRAIN WAS PLACED AND ASPIRATION WAS PERFORMED. AN ATTEMPT WAS MADE TO CROSS TO THE PERFORATION IN THE LAD WITH A 3.5X26 MM GRAFTMASTER STENT; HOWEVER, IT WOULD NOT PASS THROUGH THE OSTIUM OF THE LAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607246 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 733708

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention CONCOMITANT MEDICAL DEVICES.