BEUDAMED
    FDA Adverse Event Death Summary report: N

    INNOVA?

    MDR report key: 3926463 · Received July 10, 2014

    Report

    Report Number
    2134265-2014-04108
    Event Type
    Death
    Date Received
    July 10, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIP
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: AN INVESTIGATION OF THE RETURNED DEVICE REVEALED THAT THERE WERE NO DAMAGE OR IRREGULARITIES TO THE HANDLE, THERE WERE NO DAMAGE OR IRREGULARITIES TO THE INNER SHAFT, AND THERE WERE NO DAMAGE OR IRREGULARITIES TO THE MIDDLE SHEATH. THE OUTER SHEATH WAS BUCKLED IN NUMEROUS LOCATIONS THROUGHOUT THE STENT DELIVERY SYSTEM (SDS). THERE WAS A KINK AT THE DISTAL END OF THE NOSE CONE. THE OUTER SHEATH WAS DETACHED AT THE DISTAL END OF THE NOSE CONE, WHICH CAUSE A 3.5CM GAP BETWEEN THE SEPARATED OUTER SHAFT. THE STENT WAS PROTRUDING 20MM FROM THE OUTER SHEATH. THE DISTAL STENT STRUTS WERE STRETCHED. MICROSCOPIC EXAMINATION CONFIRMED DETACHMENT OF THE DISTAL END OF THE STENT. APPROXIMATELY 90MM OF THE STENT WAS DETACHED AND NOT RETURNED FOR ANALYSIS. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES TO THE SEPARATED STENT. THE AS-RECEIVED CONDITION OF THE DEVICE, MAINLY THE SEPARATED OUTER SHAFT, PREVENTED THE COMPLETION OF STENT DEPLOYMENT. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT AS REPORTED THAT A DEPLOYMENT ISSUE OCCURRED AND THE PATIENT SUBSEQUENTLY DIED. THE TOTALLY OCCLUDED, 200X6MM, DE NOVO TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. FOLLOWING PREDILATION, THE 6X200X130MM INNOVA¿ STENT WAS INTRODUCED. SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE STENT AND DURING STENT DEPLOYMENT WITH THE THUMBWHEEL, THE STENT WAS ONLY ABLE TO BE PARTIALLY DEPLOYED. THE PHYSICIAN PULLED ON THE GRIP, BUT IT DID NOT WORK THE STENT COULD NOT BE RETRIEVED AND THE PATIENT WAS SENT FOR OPEN SURGERY. THE PATIENT DIED THE NEXT DAY. THE PHYSICIAN CONSIDERED THE DEATH UNLIKELY RELATED TO THE DEVICE BUT WAS CONSIDERED TO BE RELATED TO A CO-MORBIDITY. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT AS REPORTED THAT A DEPLOYMENT ISSUE OCCURRED AND THE PATIENT SUBSEQUENTLY DIED. THE TOTALLY OCCLUDED, 200X6MM, DE NOVO TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. FOLLOWING PREDILATION, THE 6X200X130MM INNOVA¿ STENT WAS INTRODUCED. SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE STENT AND DURING STENT DEPLOYMENT WITH THE THUMBWHEEL, THE STENT WAS ONLY ABLE TO BE PARTIALLY DEPLOYED. THE PHYSICIAN PULLED ON THE GRIP, BUT IT DID NOT WORK THE STENT COULD NOT BE RETRIEVED AND THE PATIENT WAS SENT FOR OPEN SURGERY. THE PATIENT DIED THE NEXT DAY. THE PHYSICIAN CONSIDERED THE DEATH UNLIKELY RELATED TO THE DEVICE BUT WAS CONSIDERED TO BE RELATED TO A CO-MORBIDITY. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404714 INNOVA? STENT, SUPERFICIAL FEMORAL ARTERY NIP BOSTON SCIENTIFIC - MAPLE GROVE H74939181062030 0016570341

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| R