BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE

    MDR report key: 7245076 · Received February 6, 2018

    Report

    Report Number
    2015691-2018-00379
    Event Type
    Death
    Date Received
    February 6, 2018
    Date of Event
    November 15, 2017
    Report Date
    January 17, 2018
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    Unique Complaint ID Number,Initial or Supplement,Type of event,TTE in days,Device Brand Name,Medical device identifier,Device Codes;4142642,I,D,77,Edwards SAPIEN 3,9600TFX29,2993;4208945,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;4219977,I,D,290,Edwards SAPIEN 3,9600TFX26,3190;1290711,I,D,193,Edwards SAPIEN 3,9600TFX29,3190;1290711,I,D,217,Edwards SAPIEN 3,9600TFX29,3190;2120347,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;2120347,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;3083987,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;3083987,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;3258126,I,D,108,Edwards SAPIEN 3,9600TFX26,3190;3906045,I,D,264,Edwards SAPIEN 3,9600TFX26,3190;3986382,I,D,70,Edwards SAPIEN 3,9600TFX26,2993;4031195,I,D,103,Edwards SAPIEN 3,9600TFX26,2993;4032329,I,D,104,Edwards SAPIEN 3,9600TFX29,3190;4032329,I,D,122,Edwards SAPIEN 3,9600TFX29,3190;4129165,I,D,38,Edwards SAPIEN 3,9600TFX29,3190;4129165,I,D,42,Edwards SAPIEN 3,9600TFX29,3190;4131225,I,D,382,Edwards SAPIEN 3,9600TFX29,2993;4155310,I,D,195,Edwards SAPIEN 3,9600TFX23,3190;4204202,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;4204202,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4245592,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4245592,I,D,1,Edwards SAPIEN 3,9600TFX23,2993;4245592,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4245592,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4247264,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4247264,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4264315,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;4268336,I,D,5,Edwards SAPIEN 3,9600TFX23,2993;4276809,I,D,1,Edwards SAPIEN 3,9600TFX26,2993;4276809,I,D,1,Edwards SAPIEN 3,9600TFX26,3190;4278403,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;4285252,I,D,23,Edwards SAPIEN 3,9600TFX23,2993;4286450,I,D,59,Edwards SAPIEN 3,9600TFX26,3190;4292489,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4292489,I,D,5,Edwards SAPIEN 3,9600TFX26,2993;4292489,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4315749,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4315749,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4316502,I,D,7,Edwards SAPIEN 3,9600TFX26,2993;4316502,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4316502,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;4331607,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4338707,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4338707,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4338707,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;4343020,I,D,8,Edwards SAPIEN 3,9600TFX26,2993;4353851,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4357471,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4357471,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;4358077,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4358077,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4358077,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;4359486,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4359653,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4363843,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4378931,I,D,2,Edwards SAPIEN 3,9600TFX20,3190;4381976,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4381976,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4381976,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4381976,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;4382285,I,D,2,Edwards SAPIEN 3,9600TFX26,2993;4382578,I,D,29,Edwards SAPIEN 3,9600TFX26,3190;4384467,I,D,18,Edwards SAPIEN 3,9600TFX26,3190;4387342,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4387342,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;4389598,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4389933,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;4392520,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4392520,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;4392520,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4393305,I,D,21,Edwards SAPIEN 3,9600TFX29,2993;4393380,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4394279,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4394279,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4394279,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4394279,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;4394882,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4394882,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4396906,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;4396906,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4396906,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;4396906,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;4397799,I,D,2,Edwards SAPIEN 3,9600TFX23,2993;4397799,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4401452,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4403164,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4403164,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4403218,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;4403218,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;4403731,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4403731,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4403731,I,D,2,Edwards SAPIEN 3,9600TFX26,3190;4403731,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;4404871,I,D,1,Edwards SAPIEN 3,9600TFX26,2993;4405087,I,D,1,Edwards SAPIEN 3,9600TFX20,2993;4405352,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4405352,I,D,0,Edwards SAPIEN 3,9600TFX20,3190;4406181,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;4407587,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4408380,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4408380,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;4409045,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4409045,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4410093,I,D,1,Edwards SAPIEN 3,9600TFX20,2993;4410093,I,D,5,Edwards SAPIEN 3,9600TFX20,2993;4410093,I,D,5,Edwards SAPIEN 3,9600TFX20,2993;4411132,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4411132,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;4411132,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;4411900,I,D,60,Edwards SAPIEN 3,9600TFX26,3190;4412497,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4413567,I,D,5,Edwards SAPIEN 3,9600TFX23,2993;4414922,I,D,1,Edwards SAPIEN 3,9600TFX23,2993;4414959,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4419218,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4419387,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4419387,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4420402,I,D,3,Edwards SAPIEN 3,9600TFX20,2993;4422768,I,D,62,Edwards SAPIEN 3,9600TFX29,3190;4423157,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4423725,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4423725,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4423725,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4423725,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;4426397,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4426589,I,D,1,Edwards SAPIEN 3,9600TFX20,2993;4426589,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4426589,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4426589,I,D,0,Edwards SAPIEN 3,9600TFX20,3190;4426589,I,D,0,Edwards SAPIEN 3,9600TFX20,3190;4427415,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;4427961,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4427961,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4433406,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4434270,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4434270,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;4434433,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4436635,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4436635,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4436635,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4436635,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;4438552,I,D,12,Edwards SAPIEN 3,9600TFX23,2993;4438653,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;4440036,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4440795,I,D,3,Edwards SAPIEN 3,9600TFX26,2993;4440795,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4440795,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4440795,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;4442468,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4442689,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4444468,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4444830,I,D,2,Edwards SAPIEN 3,9600TFX29,2993;4444830,I,D,2,Edwards SAPIEN 3,9600TFX29,2993;4444830,I,D,2,Edwards SAPIEN 3,9600TFX29,3190;4445381,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4445381,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4445381,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4445381,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;4445470,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4445470,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;4445605,I,D,1,Edwards SAPIEN 3,9600TFX23,2993;4448122,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4448122,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4448124,I,D,1,Edwards SAPIEN 3,9600TFX29,2993;4448258,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4448258,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;4448417,I,D,3,Edwards SAPIEN 3,9600TFX26,2993;4448417,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4448771,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4449436,I,D,3,Edwards SAPIEN 3,9600TFX23,2993;4449436,I,D,2,Edwards SAPIEN 3,9600TFX23,2993;4449623,I,D,2,Edwards SAPIEN 3,9600TFX23,3190;4450570,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4450908,I,D,9,Edwards SAPIEN 3,9600TFX29,3190;4453931,I,D,31,Edwards SAPIEN 3,9600TFX23,2993;4454064,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4455890,I,D,2,Edwards SAPIEN 3,9600TFX20,2993;4455890,I,D,0,Edwards SAPIEN 3,9600TFX20,3190;4457286,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4457392,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4457392,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4457392,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4457392,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4457392,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4457392,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4457392,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4457392,I,D,0,Edwards SAPIEN 3,9600TFX20,3190;4457392,I,D,0,Edwards SAPIEN 3,9600TFX20,3190;4457392,I,D,0,Edwards SAPIEN 3,9600TFX20,3190;4458891,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4458891,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4458891,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4458891,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4458891,I,D,0,Edwards SAPIEN 3,9600TFX20,3190;4459768,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4459768,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;4461853,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4463305,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4463305,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4466356,I,D,1,Edwards SAPIEN 3,9600TFX20,2993;4466356,I,D,1,Edwards SAPIEN 3,9600TFX20,3190;4467469,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4467469,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;4467834,I,D,18,Edwards SAPIEN 3,9600TFX26,2993;4473709,I,D,2,Edwards SAPIEN 3,9600TFX23,2993;4474766,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4474766,I,D,1,Edwards SAPIEN 3,9600TFX23,2993;4474766,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4474766,I,D,1,Edwards SAPIEN 3,9600TFX23,3190;4475369,I,D,4,Edwards SAPIEN 3,9600TFX26,2993;4475369,I,D,4,Edwards SAPIEN 3,9600TFX26,2993;4479149,I,D,1,Edwards SAPIEN 3,9600TFX23,3190;4480466,I,D,2,Edwards SAPIEN 3,9600TFX26,2993;4481739,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4481739,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4481739,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4481739,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;4482159,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4482159,I,D,1,Edwards SAPIEN 3,9600TFX23,2993;4482159,I,D,1,Edwards SAPIEN 3,9600TFX23,2993;4482159,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;4482286,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4482443,I,D,3,Edwards SAPIEN 3,9600TFX26,2993;4482692,I,D,1,Edwards SAPIEN 3,9600TFX23,2993;4482692,I,D,1,Edwards SAPIEN 3,9600TFX23,2993;4482692,I,D,1,Edwards SAPIEN 3,9600TFX23,3190;4482874,I,D,4,Edwards SAPIEN 3,9600TFX23,2993;4483524,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4483524,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;4484761,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4484761,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;4484912,I,D,12,Edwards SAPIEN 3,9600TFX29,2993;4487163,I,D,1,Edwards SAPIEN 3,9600TFX26,2993;4487550,I,D,2,Edwards SAPIEN 3,9600TFX23,2993;4488346,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4489674,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4489756,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4489756,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4489756,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4489756,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;4489931,I,D,1,Edwards SAPIEN 3,9600TFX23,2993;4489931,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;4489961,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;4489961,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4490323,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;4490323,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4490323,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;4490323,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;4490389,I,D,1,Edwards SAPIEN 3,9600TFX26,2993;4490731,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4491498,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4491979,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4493145,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;3712941,I,D,2,Edwards SAPIEN 3,9600TFX29,3190;4194491,I,D,198,Edwards SAPIEN 3,9600TFX26,3190;4360479,I,D,4,Edwards SAPIEN 3,9600TFX29,2993;4369698,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;4461286,I,D,1,Edwards SAPIEN 3,9600TFX29,3190;4463209,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4463209,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;4463209,I,D,1,Edwards SAPIEN 3,9600TFX29,3190;4473010,I,D,2,Edwards SAPIEN 3,9600TFX29,2993;4473010,I,D,1,Edwards SAPIEN 3,9600TFX29,3190;4483304,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;3909100,S,D,228,Edwards SAPIEN 3,9600TFX23,3190;3920066,S,D,17,Edwards SAPIEN 3,9600TFX29,2993;3926228,S,D,0,Edwards SAPIEN 3,9600TFX23,2993;4049247,S,D,344,Edwards SAPIEN 3,9600TFX20,3190;4129175,S,D,362,Edwards SAPIEN 3,9600TFX26,2993;4166443,S,D,0,Edwards SAPIEN 3,9600TFX29,2993;4244876,S,D,103,Edwards SAPIEN 3,9600TFX23,3190;4244876,S,D,103,Edwards SAPIEN 3,9600TFX23,3190;4300292,S,D,4,Edwards SAPIEN 3,9600TFX26,2993

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016006, NUMBER OF DEATH EVENTS 274. COLUMN A INDICATES WHETHER AN EVENT IS A ¿NEW EVENT OR FOLLOW-UP¿. COLUMNS M AND N ASSOCIATE A DEVICE WITH THE EVENT TYPE (E.G. IT IS CONSIDERED MOST APPROPRIATE TO ASSIGN AN EVENT OF ¿MAJOR VASCULAR COMPLICATION¿ TO A SHEATH, RATHER THAN THE SAPIEN 3 VALVE). ASSOCIATED DEVICE INFORMATION IS NOT INCLUDED IN THE DATA RECEIVED FROM THE REGISTRY; THE PRODUCTS WERE ASSIGNED BY EDWARDS BASED ON STANDARD KITTING AND THE ¿IMPLANT APPROACH¿ FIELD AVAILABLE IN THE REGISTRY. ANY LINE ITEMS HIGHLIGHTED IN GREEN INDICATE USE OF A SAPIEN 3 VALVE WITH EITHER A TRANSAPICAL OR TRANSAORTIC APPROACH PRIOR TO THE COMMERCIAL APPROVAL OF THE CERTITUDE DELIVERY SYSTEM. ALTHOUGH THE ASSOCIATED DEVICE IS LISTED AS THE ¿EDWARDS CERTITUDE INTRODUCER SHEATH SET¿, IT IS POSSIBLE THAT THE ¿ASCENDRA+ INTRODUCER SHEATH SET¿ WAS THE ACTUAL SHEATH USED. THIS SPECIFIC DETAIL IS NOT PROVIDED TO EDWARDS. ANY LINE ITEMS HIGHLIGHTED IN YELLOW INDICATE A DISCREPANCY IN THE REGISTRY DATA; EXAMPLE: ¿EVENT DATE¿ PRIOR TO ¿IMPLANT DATE¿.

    Description of Event or Problem · 1

    THV/TVT REGISTRY ALTERNATIVE SUMMARY REPORT (ASR) ADVERSE EVENT SUBMISSION FOR NOVEMBER 2017 DATA EXTRACT FOR DEATH FOR THE SAPIEN 3 VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87055 EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES LLC 9600TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death