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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number 9600TFX
Device Problem Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 05/30/2018
Event Type  Death  
Manufacturer Narrative
Exemption number e2016006.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.
 
Event Description
This report summarizes 297 deaths.Thv/tvt registry alternative summary report (asr) adverse event submission for may 2018 data extract for deaths for the sapien 3 valve.
 
Event Description
Unique complaint id number,initial or supplement,type of event,tte in days,device brand name,medical device identifier,device codes
3851340,i,d,79,edwards sapien 3,9600tfx26,3190
3851340,i,d,113,edwards sapien 3,9600tfx26,3190
3851340,i,d,186,edwards sapien 3,9600tfx26,3190
3851340,i,d,179,edwards sapien 3,9600tfx26,3190
4183600,i,d,0,edwards sapien 3,9600tfx26,2993
4183600,i,d,0,edwards sapien 3,9600tfx26,3190
4194557,i,d,8,edwards sapien 3,9600tfx23,2993
4194557,i,d,8,edwards sapien 3,9600tfx23,3190
4308804,i,d,1,edwards sapien 3,9600tfx29,2993
4320942,i,d,217,edwards sapien 3,9600tfx23,3190
4348145,i,d,100,edwards sapien 3,9600tfx26,3190
4528526,i,d,1,edwards sapien 3,9600tfx29,2993
4606563,i,d,9,edwards sapien 3,9600tfx26,2993
1384569,i,d,4,edwards sapien 3,9600tfx23,3190
3993645,i,d,4,edwards sapien 3,9600tfx26,2993
4165123,i,d,60,edwards sapien 3,9600tfx20,3190
4212363,i,d,309,edwards sapien 3,9600tfx29,3190
4249641,i,d,84,edwards sapien 3,9600tfx23,3190
4348362,i,d,258,edwards sapien 3,9600tfx23,3190
4352572,i,d,4,edwards sapien 3,9600tfx29,2993
4447942,i,d,1,edwards sapien 3,9600tfx26,2993
4538556,i,d,1,edwards sapien 3,9600tfx26,2993
4538556,i,d,0,edwards sapien 3,9600tfx26,3190
4538569,i,d,0,edwards sapien 3,9600tfx23,2993
4538569,i,d,0,edwards sapien 3,9600tfx23,3190
4576037,i,d,21,edwards sapien 3,9600tfx26,2993
4612536,i,d,22,edwards sapien 3,9600tfx29,2993
4613152,i,d,0,edwards sapien 3,9600tfx23,2993
4613152,i,d,0,edwards sapien 3,9600tfx23,3190
4613152,i,d,0,edwards sapien 3,9600tfx23,2993
4613152,i,d,0,edwards sapien 3,9600tfx23,2993
4613152,i,d,0,edwards sapien 3,9600tfx23,3190
4617151,i,d,48,edwards sapien 3,9600tfx29,3190
4633637,i,d,2,edwards sapien 3,9600tfx26,2993
4635974,i,d,5,edwards sapien 3,9600tfx26,2993
4644820,i,d,0,edwards sapien 3,9600tfx23,2993
4644820,i,d,5,edwards sapien 3,9600tfx23,2993
4644820,i,d,0,edwards sapien 3,9600tfx23,3190
4645028,i,d,0,edwards sapien 3,9600tfx26,2993
4645028,i,d,0,edwards sapien 3,9600tfx26,2993
4646650,i,d,0,edwards sapien 3,9600tfx23,2993
4646650,i,d,1,edwards sapien 3,9600tfx23,2993
4647556,i,d,4,edwards sapien 3,9600tfx26,2993
4647593,i,d,1,edwards sapien 3,9600tfx29,2993
4649131,i,d,5,edwards sapien 3,9600tfx23,2993
4650242,i,d,0,edwards sapien 3,9600tfx26,2993
4650242,i,d,0,edwards sapien 3,9600tfx26,2993
4650242,i,d,0,edwards sapien 3,9600tfx26,3190
4650691,i,d,4,edwards sapien 3,9600tfx29,2993
4651636,i,d,1,edwards sapien 3,9600tfx23,2993
4651757,i,d,1,edwards sapien 3,9600tfx23,2993
4651890,i,d,1,edwards sapien 3,9600tfx23,2993
4651890,i,d,11,edwards sapien 3,9600tfx23,2993
4652806,i,d,0,edwards sapien 3,9600tfx29,3190
4654050,i,d,0,edwards sapien 3,9600tfx29,2993
4654050,i,d,0,edwards sapien 3,9600tfx29,3190
4654611,i,d,8,edwards sapien 3,9600tfx23,2993
4654753,i,d,1,edwards sapien 3,9600tfx26,2993
4654753,i,d,0,edwards sapien 3,9600tfx26,3190
4656562,i,d,0,edwards sapien 3,9600tfx23,2993
4656562,i,d,0,edwards sapien 3,9600tfx23,3190
4657229,i,d,2,edwards sapien 3,9600tfx26,2993
4657568,i,d,0,edwards sapien 3,9600tfx23,2993
4659219,i,d,4,edwards sapien 3,9600tfx29,2993
4660568,i,d,0,edwards sapien 3,9600tfx26,2993
4660568,i,d,0,edwards sapien 3,9600tfx26,2993
4660568,i,d,0,edwards sapien 3,9600tfx26,3190
4661640,i,d,2,edwards sapien 3,9600tfx26,2993
4664884,i,d,0,edwards sapien 3,9600tfx23,2993
4666436,i,d,0,edwards sapien 3,9600tfx26,2993
4666436,i,d,0,edwards sapien 3,9600tfx26,3190
4666964,i,d,1,edwards sapien 3,9600tfx23,3190
4669787,i,d,0,edwards sapien 3,9600tfx29,2993
4670035,i,d,8,edwards sapien 3,9600tfx26,2993
4670035,i,d,0,edwards sapien 3,9600tfx26,2993
4670123,i,d,1,edwards sapien 3,9600tfx29,3190
4671085,i,d,0,edwards sapien 3,9600tfx23,2993
4671085,i,d,0,edwards sapien 3,9600tfx23,2993
4671085,i,d,0,edwards sapien 3,9600tfx23,2993
4671085,i,d,0,edwards sapien 3,9600tfx23,2993
4672946,i,d,3,edwards sapien 3,9600tfx23,2993
4673115,i,d,2,edwards sapien 3,9600tfx23,2993
4673548,i,d,0,edwards sapien 3,9600tfx23,2993
4674416,i,d,48,edwards sapien 3,9600tfx26,3190
4674630,i,d,0,edwards sapien 3,9600tfx26,2993
4674630,i,d,0,edwards sapien 3,9600tfx26,3190
4675060,i,d,0,edwards sapien 3,9600tfx26,2993
4675060,i,d,0,edwards sapien 3,9600tfx26,2993
4675060,i,d,0,edwards sapien 3,9600tfx26,3190
4676491,i,d,0,edwards sapien 3,9600tfx26,2993
4676491,i,d,0,edwards sapien 3,9600tfx26,2993
4678879,i,d,0,edwards sapien 3,9600tfx23,2993
4679064,i,d,0,edwards sapien 3,9600tfx29,2993
4691359,i,d,0,edwards sapien 3,9600tfx29,2993
4691359,i,d,0,edwards sapien 3,9600tfx29,2993
4691359,i,d,0,edwards sapien 3,9600tfx29,3190
4691703,i,d,0,edwards sapien 3,9600tfx26,2993
4691703,i,d,27,edwards sapien 3,9600tfx26,2993
4693716,i,d,10,edwards sapien 3,9600tfx23,3190
4694049,i,d,1,edwards sapien 3,9600tfx23,2993
4694049,i,d,1,edwards sapien 3,9600tfx23,3190
4694049,i,d,118,edwards sapien 3,9600tfx23,3190
4694715,i,d,2,edwards sapien 3,9600tfx26,2993
4694715,i,d,0,edwards sapien 3,9600tfx26,3190
4694715,i,d,2,edwards sapien 3,9600tfx26,3190
4695146,i,d,6,edwards sapien 3,9600tfx26,2993
4695149,i,d,0,edwards sapien 3,9600tfx26,3190
4695343,i,d,0,edwards sapien 3,9600tfx23,2993
4695392,i,d,2,edwards sapien 3,9600tfx26,3190
4695473,i,d,0,edwards sapien 3,9600tfx23,2993
4696762,i,d,0,edwards sapien 3,9600tfx23,3190
4697236,i,d,2,edwards sapien 3,9600tfx29,2993
4697637,i,d,1,edwards sapien 3,9600tfx29,2993
4698138,i,d,2,edwards sapien 3,9600tfx23,2993
4699397,i,d,1,edwards sapien 3,9600tfx26,2993
4699397,i,d,1,edwards sapien 3,9600tfx26,3190
4701848,i,d,0,edwards sapien 3,9600tfx23,2993
4701848,i,d,0,edwards sapien 3,9600tfx23,2993
4701848,i,d,0,edwards sapien 3,9600tfx23,3190
4702718,i,d,0,edwards sapien 3,9600tfx23,2993
4703133,i,d,0,edwards sapien 3,9600tfx23,2993
4703133,i,d,0,edwards sapien 3,9600tfx23,3190
4703133,i,d,0,edwards sapien 3,9600tfx23,3190
4704810,i,d,0,edwards sapien 3,9600tfx26,3190
4704855,i,d,6,edwards sapien 3,9600tfx23,2993
4706466,i,d,1,edwards sapien 3,9600tfx26,2993
4709058,i,d,1,edwards sapien 3,9600tfx29,2993
4709372,i,d,2,edwards sapien 3,9600tfx23,2993
4712882,i,d,8,edwards sapien 3,9600tfx23,2993
4714006,i,d,35,edwards sapien 3,9600tfx23,3190
4714842,i,d,1,edwards sapien 3,9600tfx23,2993
4715043,i,d,2,edwards sapien 3,9600tfx23,3190
4716370,i,d,7,edwards sapien 3,9600tfx23,3190
4716370,i,d,0,edwards sapien 3,9600tfx23,3190
4716447,i,d,0,edwards sapien 3,9600tfx29,2993
4716447,i,d,0,edwards sapien 3,9600tfx29,3190
4716642,i,d,0,edwards sapien 3,9600tfx23,2993
4716652,i,d,15,edwards sapien 3,9600tfx26,3190
4717105,i,d,0,edwards sapien 3,9600tfx29,2993
4717105,i,d,0,edwards sapien 3,9600tfx29,2993
4717105,i,d,0,edwards sapien 3,9600tfx29,3190
4717204,i,d,1,edwards sapien 3,9600tfx29,2993
4717534,i,d,0,edwards sapien 3,9600tfx29,2993
4717534,i,d,0,edwards sapien 3,9600tfx29,2993
4717534,i,d,0,edwards sapien 3,9600tfx29,2993
4717534,i,d,0,edwards sapien 3,9600tfx29,2993
4717843,i,d,0,edwards sapien 3,9600tfx23,2993
4717843,i,d,2,edwards sapien 3,9600tfx23,2993
4717843,i,d,0,edwards sapien 3,9600tfx23,2993
4717843,i,d,0,edwards sapien 3,9600tfx23,3190
4718840,i,d,0,edwards sapien 3,9600tfx29,3190
4719413,i,d,0,edwards sapien 3,9600tfx26,2993
4719413,i,d,6,edwards sapien 3,9600tfx26,3190
4719413,i,d,1,edwards sapien 3,9600tfx26,3190
4720856,i,d,0,edwards sapien 3,9600tfx23,2993
4720856,i,d,0,edwards sapien 3,9600tfx23,3190
4723935,i,d,0,edwards sapien 3,9600tfx23,2993
4723935,i,d,0,edwards sapien 3,9600tfx23,2993
4723935,i,d,0,edwards sapien 3,9600tfx23,3190
4723965,i,d,12,edwards sapien 3,9600tfx26,3190
4725623,i,d,1,edwards sapien 3,9600tfx20,2993
4725623,i,d,1,edwards sapien 3,9600tfx20,3190
4725826,i,d,0,edwards sapien 3,9600tfx26,2993
4727362,i,d,0,edwards sapien 3,9600tfx23,2993
4727362,i,d,0,edwards sapien 3,9600tfx23,3190
4727758,i,d,1,edwards sapien 3,9600tfx26,2993
4729635,i,d,7,edwards sapien 3,9600tfx23,2993
4729635,i,d,7,edwards sapien 3,9600tfx23,2993
4729641,i,d,0,edwards sapien 3,9600tfx29,2993
4730228,i,d,0,edwards sapien 3,9600tfx26,3190
4730682,i,d,17,edwards sapien 3,9600tfx26,2993
4731179,i,d,0,edwards sapien 3,9600tfx23,2993
4731179,i,d,0,edwards sapien 3,9600tfx23,2993
4731179,i,d,0,edwards sapien 3,9600tfx23,2993
4731179,i,d,0,edwards sapien 3,9600tfx23,3190
4731501,i,d,0,edwards sapien 3,9600tfx29,3190
4731501,i,d,0,edwards sapien 3,9600tfx29,2993
4731501,i,d,0,edwards sapien 3,9600tfx29,2993
4731501,i,d,0,edwards sapien 3,9600tfx29,3190
4732420,i,d,1,edwards sapien 3,9600tfx29,2993
4732440,i,d,0,edwards sapien 3,9600tfx23,2993
4732480,i,d,0,edwards sapien 3,9600tfx29,2993
4732480,i,d,0,edwards sapien 3,9600tfx29,2993
4732891,i,d,7,edwards sapien 3,9600tfx29,2993
4732891,i,d,7,edwards sapien 3,9600tfx29,2993
4732891,i,d,7,edwards sapien 3,9600tfx29,3190
4734459,i,d,0,edwards sapien 3,9600tfx26,2993
4734459,i,d,0,edwards sapien 3,9600tfx26,3190
4734459,i,d,0,edwards sapien 3,9600tfx26,3190
4734792,i,d,1,edwards sapien 3,9600tfx23,2993
4736787,i,d,0,edwards sapien 3,9600tfx26,3190
4736931,i,d,1,edwards sapien 3,9600tfx23,3190
4737112,i,d,11,edwards sapien 3,9600tfx26,2993
4737708,i,d,15,edwards sapien 3,9600tfx23,2993
4738618,i,d,1,edwards sapien 3,9600tfx29,2993
4738618,i,d,0,edwards sapien 3,9600tfx29,2993
4738618,i,d,0,edwards sapien 3,9600tfx29,3190
4739280,i,d,0,edwards sapien 3,9600tfx23,2993
4739280,i,d,0,edwards sapien 3,9600tfx23,2993
4739280,i,d,0,edwards sapien 3,9600tfx23,3190
4739280,i,d,3,edwards sapien 3,9600tfx23,3190
4739361,i,d,1,edwards sapien 3,9600tfx23,2993
4741565,i,d,0,edwards sapien 3,9600tfx23,3190
4741792,i,d,11,edwards sapien 3,9600tfx23,2993
4753032,i,d,0,edwards sapien 3,9600tfx23,2993
4753032,i,d,0,edwards sapien 3,9600tfx23,2993
4753032,i,d,0,edwards sapien 3,9600tfx23,2993
4753032,i,d,0,edwards sapien 3,9600tfx23,3190
4753058,i,d,1,edwards sapien 3,9600tfx26,2993
4754312,i,d,0,edwards sapien 3,9600tfx26,2993
4754312,i,d,0,edwards sapien 3,9600tfx26,2993
4754312,i,d,0,edwards sapien 3,9600tfx26,2993
4757488,i,d,0,edwards sapien 3,9600tfx26,2993
4757606,i,d,44,edwards sapien 3,9600tfx20,3190
4758159,i,d,0,edwards sapien 3,9600tfx29,2993
4758159,i,d,0,edwards sapien 3,9600tfx29,3190
4758528,i,d,1,edwards sapien 3,9600tfx23,3190
4759664,i,d,0,edwards sapien 3,9600tfx26,2993
4760739,i,d,0,edwards sapien 3,9600tfx23,2993
4760764,i,d,0,edwards sapien 3,9600tfx26,2993
4760764,i,d,0,edwards sapien 3,9600tfx26,2993
4760764,i,d,0,edwards sapien 3,9600tfx26,3190
4762139,i,d,0,edwards sapien 3,9600tfx26,2993
4762574,i,d,1,edwards sapien 3,9600tfx29,3190
4763649,i,d,0,edwards sapien 3,9600tfx26,2993
4763719,i,d,0,edwards sapien 3,9600tfx29,2993
4763719,i,d,0,edwards sapien 3,9600tfx29,3190
4763768,i,d,0,edwards sapien 3,9600tfx23,2993
4763768,i,d,0,edwards sapien 3,9600tfx23,2993
4763768,i,d,0,edwards sapien 3,9600tfx23,3190
4763768,i,d,0,edwards sapien 3,9600tfx23,3190
4764944,i,d,2,edwards sapien 3,9600tfx29,2993
4765438,i,d,0,edwards sapien 3,9600tfx29,2993
4765604,i,d,0,edwards sapien 3,9600tfx29,3190
4765747,i,d,0,edwards sapien 3,9600tfx23,2993
4766280,i,d,0,edwards sapien 3,9600tfx23,3190
4766424,i,d,0,edwards sapien 3,9600tfx23,2993
4766424,i,d,0,edwards sapien 3,9600tfx23,2993
4766806,i,d,5,edwards sapien 3,9600tfx23,3190
4767075,i,d,2,edwards sapien 3,9600tfx23,2993
4767353,i,d,0,edwards sapien 3,9600tfx29,2993
4767767,i,d,3,edwards sapien 3,9600tfx26,2993
4767767,i,d,0,edwards sapien 3,9600tfx26,2993
4767767,i,d,0,edwards sapien 3,9600tfx26,2993
4767767,i,d,2,edwards sapien 3,9600tfx26,2993
4769034,i,d,1,edwards sapien 3,9600tfx23,2993
4769161,i,d,1,edwards sapien 3,9600tfx23,2993
4780333,i,d,1,edwards sapien 3,9600tfx29,2993
4781060,i,d,2,edwards sapien 3,9600tfx29,2993
4781155,i,d,9,edwards sapien 3,9600tfx23,2993
4792600,i,d,0,edwards sapien 3,9600tfx23,2993
4792600,i,d,1,edwards sapien 3,9600tfx23,2993
4792600,i,d,0,edwards sapien 3,9600tfx23,3190
4792600,i,d,1,edwards sapien 3,9600tfx23,3190
4794235,i,d,0,edwards sapien 3,9600tfx23,3190
4794235,i,d,0,edwards sapien 3,9600tfx23,2993
4794235,i,d,0,edwards sapien 3,9600tfx23,3190
4794235,i,d,0,edwards sapien 3,9600tfx23,2993
4794235,i,d,0,edwards sapien 3,9600tfx23,2993
4794235,i,d,0,edwards sapien 3,9600tfx23,3190
4794884,i,d,12,edwards sapien 3,9600tfx29,2993
4794884,i,d,13,edwards sapien 3,9600tfx29,3190
4794935,i,d,0,edwards sapien 3,9600tfx23,2993
4320942,i,d,0,edwards sapien 3,9600tfx29,3190
4245671,i,d,0,edwards sapien 3,9600tfx29,2993
4245671,i,d,0,edwards sapien 3,9600tfx29,3190
4245671,i,d,0,edwards sapien 3,9600tfx29,3190
4245671,i,d,0,edwards sapien 3,9600tfx29,2993
4645080,i,d,0,edwards sapien 3,9600tfx29,3190
4645080,i,d,0,edwards sapien 3,9600tfx29,3190
4652015,i,d,0,edwards sapien 3,9600tfx26,2993
4652015,i,d,0,edwards sapien 3,9600tfx26,3190
4652015,i,d,0,edwards sapien 3,9600tfx26,2993
4652015,i,d,0,edwards sapien 3,9600tfx26,3190
4662596,i,d,0,edwards sapien 3,9600tfx26,2993
4663305,i,d,19,edwards sapien 3,9600tfx29,2993
4667222,i,d,0,edwards sapien 3,9600tfx29,2993
4667222,i,d,0,edwards sapien 3,9600tfx29,3190
4667222,i,d,0,edwards sapien 3,9600tfx29,3190
4678508,i,d,0,edwards sapien 3,9600tfx29,2993
4715034,i,d,1,edwards sapien 3,9600tfx29,3190
4761348,i,d,14,edwards sapien 3,9600tfx29,3190
4761348,i,d,0,edwards sapien 3,9600tfx29,2993
4761348,i,d,14,edwards sapien 3,9600tfx29,3190
4765801,i,d,0,edwards sapien 3,9600tfx29,2993
4765801,i,d,0,edwards sapien 3,9600tfx29,2993
4765801,i,d,0,edwards sapien 3,9600tfx29,3190
4195908,s,d,56,edwards sapien 3,9600tfx23,3190
4265662,s,d,56,edwards sapien 3,9600tfx23,3190
4357927,s,d,0,edwards sapien 3,9600tfx23,2993
4481930,s,d,0,edwards sapien 3,9600tfx29,2993
4481930,s,d,0,edwards sapien 3,9600tfx29,2993
4493723,s,d,5,edwards sapien 3,9600tfx23,2993
4570924,s,d,3,edwards sapien 3,9600tfx26,2993
4637680,s,d,10,edwards sapien 3,9600tfx26,2993
4642004,s,d,63,edwards sapien 3,9600tfx26,3190
4644706,s,d,0,edwards sapien 3,9600tfx29,3190.
 
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Brand Name
EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
Type of Device
AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Manufacturer (Section D)
EDWARDS LIFESCIENCES
1 edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
1 edwards way
irvine CA 92614
Manufacturer Contact
frances preston
1 edwards way
irvine, CA 92614
9492505190
MDR Report Key7894959
MDR Text Key120960030
Report Number2015691-2018-03871
Device Sequence Number1
Product Code NPT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Model Number9600TFX
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/31/2018
Initial Date FDA Received09/20/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
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