BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 9421190 · Received December 5, 2019

    Report

    Report Number
    2015691-2019-04496
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    August 9, 2019
    Report Date
    November 25, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    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

    Additional Manufacturer Narrative · 0

    THIS REPORT SUMMARIZES <NOE> 259 </NOE> DEATH EVENTS SAPIEN 3 VALVE, SUPPLEMENTAL REPORT TO REFLECT NOE NUMBER.

    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;4741143,I,D,314,Edwards SAPIEN 3,9600TFX20,3190;4797148,I,D,269,Edwards SAPIEN 3,9600TFX26,3190;4919136,I,D,63,Edwards SAPIEN 3,9600TFX23,2993;4919136,I,D,63,Edwards SAPIEN 3,9600TFX23,3190;5011208,I,D,166,Edwards SAPIEN 3,9600TFX23,3190;5011208,I,D,147,Edwards SAPIEN 3,9600TFX23,3190;5011208,I,D,166,Edwards SAPIEN 3,9600TFX23,3190;5156147,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5156147,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5354459,I,D,8,Edwards SAPIEN 3,9600TFX23,2993;1133197,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;1133197,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;2707230,I,D,2,Edwards SAPIEN 3,9600TFX26,3190;2735044,I,D,2,Edwards SAPIEN 3,9600TFX26,2993;2735044,I,D,2,Edwards SAPIEN 3,9600TFX26,3190;3012997,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;4078586,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;4078586,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;4394879,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4722892,I,D,170,Edwards SAPIEN 3,9600TFX26,3190;4722892,I,D,178,Edwards SAPIEN 3,9600TFX26,3190;4736282,I,D,55,Edwards SAPIEN 3,9600TFX23,3190;4736282,I,D,209,Edwards SAPIEN 3,9600TFX23,3190;4765112,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;4835073,I,D,341,Edwards SAPIEN 3,9600TFX23,3190;4836516,I,D,103,Edwards SAPIEN 3,9600TFX23,3190;4837265,I,D,360,Edwards SAPIEN 3,9600TFX29,3190;4868826,I,D,122,Edwards SAPIEN 3,9600TFX29,3190;4905460,I,D,267,Edwards SAPIEN 3,9600TFX23,3190;4917232,I,D,187,Edwards SAPIEN 3,9600TFX23,3190;4922137,I,D,55,Edwards SAPIEN 3,9600TFX23,3190;4934311,I,D,105,Edwards SAPIEN 3,9600TFX26,3190;5198569,I,D,155,Edwards SAPIEN 3,9600TFX23,3190;5200057,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5216345,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5216345,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5216345,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5216345,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5233623,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5233623,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5236943,I,D,1,Edwards SAPIEN 3,9600TFX26,2993;5237059,I,D,4,Edwards SAPIEN 3,9600TFX23,2993;5292040,I,D,4,Edwards SAPIEN 3,9600TFX23,2993;5292040,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;5293263,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5310738,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5310738,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5357621,I,D,11,Edwards SAPIEN 3,9600TFX20,2993;5358680,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5358680,I,D,1,Edwards SAPIEN 3,9600TFX23,2993;5358680,I,D,1,Edwards SAPIEN 3,9600TFX23,2993;5358680,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;5389564,I,D,6,Edwards SAPIEN 3,9600TFX29,2993;5403937,I,D,8,Edwards SAPIEN 3,9600TFX23,3190;5408800,I,D,3,Edwards SAPIEN 3,9600TFX23,2993;5409565,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5412401,I,D,2,Edwards SAPIEN 3,9600TFX23,2993;5413226,I,D,2,Edwards SAPIEN 3,9600TFX26,2993;5413236,I,D,1,Edwards SAPIEN 3,9600TFX29,2993;5413286,I,D,2,Edwards SAPIEN 3,9600TFX26,2993;5413286,I,D,2,Edwards SAPIEN 3,9600TFX26,2993;5413286,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5414638,I,D,3,Edwards SAPIEN 3,9600TFX20,2993;5414638,I,D,3,Edwards SAPIEN 3,9600TFX20,3190;5414638,I,D,3,Edwards SAPIEN 3,9600TFX20,3190;5414641,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5414641,I,D,3,Edwards SAPIEN 3,9600TFX23,3190;5416477,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;5427003,I,D,3,Edwards SAPIEN 3,9600TFX23,3190;5428156,I,D,4,Edwards SAPIEN 3,9600TFX23,2993;5428156,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5428156,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5428156,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;5438597,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5438708,I,D,5,Edwards SAPIEN 3,9600TFX29,2993;5438708,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5438708,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5438954,I,D,35,Edwards SAPIEN 3,9600TFX29,3190;5441457,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;5442178,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5442178,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5442178,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;5442428,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5442428,I,D,2,Edwards SAPIEN 3,9600TFX29,3190;5443809,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5443884,I,D,1,Edwards SAPIEN 3,9600TFX29,2993;5444044,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5444044,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5444251,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5447634,I,D,2,Edwards SAPIEN 3,9600TFX26,2993;5449745,I,D,1,Edwards SAPIEN 3,9600TFX26,2993;5450008,I,D,4,Edwards SAPIEN 3,9600TFX20,2993;5451799,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5451799,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5454141,I,D,4,Edwards SAPIEN 3,9600TFX23,2993;5454470,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;5454849,I,D,5,Edwards SAPIEN 3,9600TFX26,2993;5454878,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5455284,I,D,1,Edwards SAPIEN 3,9600TFX26,2993;5456563,I,D,3,Edwards SAPIEN 3,9600TFX26,2993;5457281,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;5457760,I,D,0,Edwards SAPIEN 3,9600TFX20,2993;5457760,I,D,53,Edwards SAPIEN 3,9600TFX20,3190;5459088,I,D,1,Edwards SAPIEN 3,9600TFX26,3190;5462471,I,D,6,Edwards SAPIEN 3,9600TFX20,3190;5463370,I,D,1,Edwards SAPIEN 3,9600TFX29,2993;5463370,I,D,27,Edwards SAPIEN 3,9600TFX29,3190;5463770,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5467356,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5467356,I,D,1,Edwards SAPIEN 3,9600TFX29,2993;5467356,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5467356,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5467356,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;5468621,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5468621,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5469041,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;5470489,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5470489,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5470489,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5470489,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5470489,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5471349,I,D,32,Edwards SAPIEN 3,9600TFX23,3190;5472096,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5474394,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5475443,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5475443,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5475443,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5475443,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;5476831,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5488054,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5488629,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;5488629,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;5489312,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5489401,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5489401,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5489401,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5489411,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5489411,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5489411,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5489514,I,D,3,Edwards SAPIEN 3,9600TFX29,2993;5489514,I,D,1,Edwards SAPIEN 3,9600TFX29,2993;5492319,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5492319,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;5493201,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5494446,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5494858,I,D,6,Edwards SAPIEN 3,9600TFX26,2993;5495213,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5496198,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5497098,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5497482,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5499526,I,D,5,Edwards SAPIEN 3,9600TFX29,2993;5500801,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5502773,I,D,24,Edwards SAPIEN 3,9600TFX26,3190;5504491,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5504491,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5504837,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5504837,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5504837,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5504837,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5504850,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5505662,I,D,1,Edwards SAPIEN 3,9600TFX26,2993;5507075,I,D,2,Edwards SAPIEN 3,9600TFX23,2993;5507075,I,D,2,Edwards SAPIEN 3,9600TFX23,2993;5507075,I,D,2,Edwards SAPIEN 3,9600TFX23,2993;5507075,I,D,2,Edwards SAPIEN 3,9600TFX23,3190;5507431,I,D,1,Edwards SAPIEN 3,9600TFX29,2993;5508281,I,D,1,Edwards SAPIEN 3,9600TFX23,2993;5510234,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5510234,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5510234,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;5511599,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;5512170,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5512170,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5512170,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5513785,I,D,25,Edwards SAPIEN 3,9600TFX23,2993;5515976,I,D,1,Edwards SAPIEN 3,9600TFX29,2993;5517855,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;5518238,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;5518238,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;5522702,I,D,3,Edwards SAPIEN 3,9600TFX26,2993;5524301,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;5534436,I,D,1,Edwards SAPIEN 3,9600TFX26,2993;5545016,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5545016,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5545016,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5545129,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5546032,I,D,1,Edwards SAPIEN 3,9600TFX20,2993;5546544,I,D,1,Edwards SAPIEN 3,9600TFX26,2993;5546544,I,D,4,Edwards SAPIEN 3,9600TFX26,2993;5546544,I,D,2,Edwards SAPIEN 3,9600TFX26,3190;5547188,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5547188,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5549731,I,D,1,Edwards SAPIEN 3,9600TFX29,2993;5550741,I,D,5,Edwards SAPIEN 3,9600TFX29,3190;5551628,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5551628,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5551628,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;5551632,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5551632,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5551632,I,D,1,Edwards SAPIEN 3,9600TFX29,2993;5551632,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;5552059,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5552059,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5553899,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5553899,I,D,0,Edwards SAPIEN 3,9600TFX23,3190;5554938,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5555059,I,D,18,Edwards SAPIEN 3,9600TFX29,2993;5555963,I,D,1,Edwards SAPIEN 3,9600TFX20,2993;5556288,I,D,1,Edwards SAPIEN 3,9600TFX29,2993;5566447,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5566447,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5567595,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5567595,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5568009,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;5568392,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5568392,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5568392,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;5568476,I,D,1,Edwards SAPIEN 3,9600TFX29,2993;5568617,I,D,0,Edwards SAPIEN 3,9600TFX26,2993;5568617,I,D,8,Edwards SAPIEN 3,9600TFX26,2993;5569734,I,D,3,Edwards SAPIEN 3,9600TFX26,2993;5570993,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5570993,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;5571637,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5571637,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;5572465,I,D,1,Edwards SAPIEN 3,9600TFX29,2993;5572465,I,D,13,Edwards SAPIEN 3,9600TFX29,2993;5573840,I,D,2,Edwards SAPIEN 3,9600TFX23,2993;5574234,I,D,1,Edwards SAPIEN 3,9600TFX26,2993;5574234,I,D,0,Edwards SAPIEN 3,9600TFX26,3190;5574234,I,D,1,Edwards SAPIEN 3,9600TFX26,3190;5575162,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;5575162,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5575162,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5580237,I,D,0,Edwards SAPIEN 3,9600TFX23,2993;4741143,I,D,314,Edwards SAPIEN 3,9600TFX26,3190;5457760,I,D,21,Edwards SAPIEN 3,9600TFX29,3190;5411506,I,D,30,Edwards SAPIEN 3,9600TFX29,3190;5443342,I,D,1,Edwards SAPIEN 3,9600TFX29,2993;5443342,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;5465854,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;5465870,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;5465870,I,D,1,Edwards SAPIEN 3,9600TFX29,2993;5465870,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;5465870,I,D,1,Edwards SAPIEN 3,9600TFX29,2993;5513995,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;5513995,I,D,0,Edwards SAPIEN 3,9600TFX29,3190;5520936,I,D,2,Edwards SAPIEN 3,9600TFX23,2993;5578265,I,D,1,Edwards SAPIEN 3,9600TFX29,2993;5578265,I,D,0,Edwards SAPIEN 3,9600TFX29,2993;4795729,S,D,353,Edwards SAPIEN 3,9600TFX26,3190;4797308,S,D,283,Edwards SAPIEN 3,9600TFX29,3190;4797308,S,D,304,Edwards SAPIEN 3,9600TFX29,3190;4823287,S,D,227,Edwards SAPIEN 3,9600TFX23,3190;4823287,S,D,286,Edwards SAPIEN 3,9600TFX23,3190;4826893,S,D,0,Edwards SAPIEN 3,9600TFX23,2993;5320394,S,D,7,Edwards SAPIEN 3,9600TFX23,3190;5382113,S,D,31,Edwards SAPIEN 3,9600TFX29,3190;5382794,S,D,0,Edwards SAPIEN 3,9600TFX23,2993

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016006, THIS REPORT SUMMARIZES 259 DEATH EVENTS. 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 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 REPORTING (ASR) ADVERSE EVENT SUBMISSION FOR (B)(6) 2019 DATA EXTRACT FOR DEATH FOR THE SAPIEN 3 VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213051 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death