BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUTRAK DELIVERY CATHETER SYSTEM

    MDR report key: 3874152 · Received June 16, 2014

    Report

    Report Number
    2025587-2014-00383
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 16, 2014
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE DEVICE WOULD BE RETURNED FOR ANALYSIS; TO DATE, THE DEVICE HAS NOT BEEN RETURNED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED OR FOLLOWING THE COMPLETION OF THE ANALYSIS/INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, THE DELIVERY CATHETER SYSTEM (DCS) WAS RECEIVED LOOSE IN THE ORIGINAL PRODUCT CONTAINER. THE DISTAL TIP OF THE PLUNGER, WHICH WAS SEPARATE FROM THE PLUNGER TUBE AT THE TIME OF RECEIPT, WAS RECEIVED WITH THE CATHETER. THE DCS HANDLE WAS INTACT. THE MICRO KNOB (THUMB WHEEL) RETRACTED AND ADVANCED THE CAPSULE. THE MACRO (CURSOR) MOVED TO FULLY ADVANCED AND RETRACTED POSITIONS AND LOCKED IN PLACE WHEN RELEASED. SEVERAL KINKS (TELESCOPING) WERE OBSERVED ALONG THE CAPSULE BETWEEN THE PROXIMAL AND DISTAL ENDS. A KINK WAS OBSERVED ON THE PROXIMAL END OF THE CAPSULE. TINY STRESS MARKS WERE OBSERVED ON THE DISTAL TIP OF THE CAPSULE ALONG THE RADIOPAQUE MARKER BAND. THE DETACHMENT APPEARED TO BE ASSOCIATED WITH THE PULL FORCE APPLIED ON THE HEAD OF THE PLUNGER WHILE RETRACTING THE DISTAL END THROUGH THE INTRODUCER SHEATH WITHOUT THE SUPPORT OF THE CAPSULE. THE PLUNGER TUBE SHOWED THREE KINKS AND ELONGATION. DEFORMATION OR GOUGE MARKS ON BOTH CATHETER TABS APPEARED TO BE DUE TO WEAR FROM THE VALVE FRAME LOOP UPON DEPLOYMENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. DEVICE ANALYSIS CONFIRMED THE BROKEN PLUNGER TIP. THE PLUNGER TUBE WAS ELONGATED AND KINKED AND THE PLUNGER TIP WAS COMPLETELY SEPARATED FROM THE END OF THE TUBE. IT IS UNKNOWN WHY THE VALVE WAS INITIALLY LOW AND HOW MUCH OF THE VALVE WAS DEPLOYED. TENSION IN THE SYSTEM, AND THE INTERACTION BETWEEN THE SYSTEM AND THE ANATOMY, CAN CONTRIBUTE TO POSITIONING DIFFICULTIES AND DISLODGEMENTS. VALVE RETRIEVAL AFTER PARTIAL DEPLOYMENT IS NOT RECOMMENDED IN THE INSTRUCTIONS FOR USE (IFU). THE ANGIOGRAPHIC PROCEDURAL RECORD WAS REQUESTED BUT NOT RECEIVED FOR REVIEW; THEREFORE, THE FULL ORDER OF EVENTS IS NOT CLEAR AND IT IS UNKNOWN WHAT THE PLUNGER TIP CAUGHT ON. BASED ON THE REPORTED INFORMATION AND THE RETURNED DEVICE ANALYSIS, IT CAN BE CONCLUDED THAT BECAUSE THE VALVE WAS PARTIALLY DEPLOYED, THE CAPSULE COULD NOT FULLY SEAT AGAINST THE PLUNGER TO SUPPORT IT; THE GAP ALLOWED THE PLUNGER TIP TO SNAG AND THE USER CONTINUED TO APPLY FORCE, CAUSING THE PLUNGER TO STRETCH AND THEN BREAK. IT IS UNKNOWN WHY THE GUIDEWIRE SUBSEQUENTLY WAS PULLED FREE OF THE SEPARATED PLUNGER TIP. THE OBSERVED DAMAGE TO THE CATHETER TABS LIKELY WAS CAUSED BY THE FORCE OF THE FRAME LOOPS ON THE TABS DURING VALVE RETRIEVAL. THE OBSERVED TELESCOPING ALONG THE CAPSULE WAS LIKELY ASSOCIATED WITH TRACKING THE DEVICE OVER THE AORTIC ARCH.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, IT WAS DETERMINED THAT THE VALVE WAS TOO DEEP. AN ATTEMPT WAS MADE TO MOVE THE VALVE HIGHER, AS IT WAS STILL ATTACHED TO THE DELIVERY CATHETER SYSTEM (DCS), BUT THE VALVE MOVED OUT OF THE ANNULUS. RETRIEVAL OF THE VALVE FROM THE PATIENT WAS BEGUN BY PULLING THE VALVE STEP-BY-STEP INTO THE SHEATH WITH THE CAPSULE CLOSED ONLY HALFWAY. THE NOSE CONE DETACHED FROM THE DCS AND THE VALVE RELEASED IN FRONT OF THE KIDNEY ARTERIES. PERFUSION OF THE KIDNEYS WAS CONFIRMED TO BE WITHOUT OCCLUSION. THE DCS WAS REMOVED FROM THE SHEATH, AND THE NOSE CONE WAS SNARED AND REMOVED FROM THE PATIENT. THE PHYSICIAN DECIDED THAT A SECOND BIOPROSTHETIC VALVE IMPLANT ATTEMPT WOULD NOT BE MADE AT THAT TIME, AS THE PATIENT HAD DIFFICULT FEMORAL ACCESS. THE PATIENT WILL BE ASSESSED FOR RECEIPT OF ANOTHER VALVE VIA APICAL ACCESS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE FOLLOWING ADDITIONAL DETAILS SUBSEQUENTLY WERE PROVIDED: THE NOSE CONE REMAINED ON THE GUIDEWIRE UNTIL SHORTLY BEFORE IT REACHED THE INTRODUCER SHEATH. THE NOSE CONE REMAINED LOCATED IN FRONT OF THE SHEATH UNTIL IT WAS SNARED AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352527 ACCUTRAK DELIVERY CATHETER SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT HEART VALVES SANTA ANA DCS-C4-18FR 0007108550

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention