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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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EDWARDS LIFESCIENCES LLC EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number 9600TFX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 08/20/2018
Event Type  Injury  
Manufacturer Narrative
Exemption number e2016006.This report summarizes 1873 serious injury 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".
 
Event Description
Thv/tvt registry alternative summary report (asr) adverse event submission for (b)(6) 2018 data extract for serious injuries 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
3924859,i,si,3,edwards sapien 3,9600tfx26,2993
4131946,i,si,184,edwards sapien 3,9600tfx20,3190
4181980,i,si,183,edwards sapien 3,9600tfx23,3190
4238900,i,si,12,edwards sapien 3,9600tfx29,2993
4253901,i,si,1,edwards sapien 3,9600tfx23,2993
4311502,i,si,267,edwards sapien 3,9600tfx26,3190
4311502,i,si,297,edwards sapien 3,9600tfx26,3190
4313066,i,si,34,edwards sapien 3,9600tfx29,3190
4318481,i,si,365,edwards sapien 3,9600tfx26,3190
4369083,i,si,64,edwards sapien 3,9600tfx23,2993
4369083,i,si,48,edwards sapien 3,9600tfx23,2993
2002370,i,si,108,edwards sapien 3,9600tfx23,3190
4250828,i,si,17,edwards sapien 3,9600tfx26,3190
4397060,i,si,203,edwards sapien 3,9600tfx23,3190
4406201,i,si,398,edwards sapien 3,9600tfx23,3190
4406201,i,si,398,edwards sapien 3,9600tfx23,3190
4471046,i,si,134,edwards sapien 3,9600tfx23,3190
4390889,i,si,77,edwards sapien 3,9600tfx23,3190
4390889,i,si,77,edwards sapien 3,9600tfx23,3190
4390889,i,si,33,edwards sapien 3,9600tfx23,3190
4390889,i,si,47,edwards sapien 3,9600tfx23,3190
4390889,i,si,31,edwards sapien 3,9600tfx23,3190
4390889,i,si,112,edwards sapien 3,9600tfx23,3190
4390889,i,si,266,edwards sapien 3,9600tfx23,3190
4390889,i,si,298,edwards sapien 3,9600tfx23,3190
4611824,i,si,4,edwards sapien 3,9600tfx26,3190
4623754,i,si,0,edwards sapien 3,9600tfx23,3190
4643773,i,si,0,edwards sapien 3,9600tfx20,2993
4643773,i,si,0,edwards sapien 3,9600tfx20,2993
4700001,i,si,1,edwards sapien 3,9600tfx26,2993
4725472,i,si,16,edwards sapien 3,9600tfx23,3190
4741682,i,si,3,edwards sapien 3,9600tfx26,3190
4758472,i,si,0,edwards sapien 3,9600tfx23,2993
4758472,i,si,0,edwards sapien 3,9600tfx23,3190
4759403,i,si,10,edwards sapien 3,9600tfx26,2993
4792705,i,si,0,edwards sapien 3,9600tfx26,3190
1099517,i,si,0,edwards sapien 3,9600tfx26,2993
1180992,i,si,3,edwards sapien 3,9600tfx26,2993
1517315,i,si,27,edwards sapien 3,9600tfx23,3190
1722809,i,si,0,edwards sapien 3,9600tfx26,3190
1752359,i,si,3,edwards sapien 3,9600tfx23,2993
1827837,i,si,14,edwards sapien 3,9600tfx29,3190
2049100,i,si,29,edwards sapien 3,9600tfx29,2993
2250221,i,si,5,edwards sapien 3,9600tfx23,2993
2258044,i,si,2,edwards sapien 3,9600tfx26,2993
2327494,i,si,0,edwards sapien 3,9600tfx23,2993
2327494,i,si,0,edwards sapien 3,9600tfx23,2993
2327494,i,si,0,edwards sapien 3,9600tfx23,3190
2422399,i,si,0,edwards sapien 3,9600tfx20,3190
2435145,i,si,9,edwards sapien 3,9600tfx23,2993
2475891,i,si,0,edwards sapien 3,9600tfx29,3190
2583057,i,si,1,edwards sapien 3,9600tfx29,2993
27570,i,si,1,edwards sapien 3,9600tfx29,2993
2784023,i,si,3,edwards sapien 3,9600tfx26,3190
2839083,i,si,-1676,edwards sapien 3,9600tfx23,3190
2839083,i,si,-1637,edwards sapien 3,9600tfx23,3190
3028411,i,si,2,edwards sapien 3,9600tfx26,2993
3029818,i,si,0,edwards sapien 3,9600tfx26,2993
3165202,i,si,369,edwards sapien 3,9600tfx29,3190
3165202,i,si,391,edwards sapien 3,9600tfx29,3190
32186,i,si,0,edwards sapien 3,9600tfx29,2993
3221585,i,si,14,edwards sapien 3,9600tfx26,2993
3256711,i,si,0,edwards sapien 3,9600tfx26,3190
3300286,i,si,333,edwards sapien 3,9600tfx26,3190
3319978,i,si,0,edwards sapien 3,9600tfx23,3190
3340963,i,si,2,edwards sapien 3,9600tfx29,2993
3450740,i,si,2,edwards sapien 3,9600tfx29,3190
3763825,i,si,1,edwards sapien 3,9600tfx23,2993
3785248,i,si,1,edwards sapien 3,9600tfx26,2993
3938912,i,si,0,edwards sapien 3,9600tfx23,3190
3953470,i,si,2,edwards sapien 3,9600tfx29,2993
3953470,i,si,0,edwards sapien 3,9600tfx29,3190
3955635,i,si,0,edwards sapien 3,9600tfx23,2993
4004595,i,si,4,edwards sapien 3,9600tfx26,2993
4024918,i,si,1,edwards sapien 3,9600tfx29,2993
4079678,i,si,5,edwards sapien 3,9600tfx26,3190
4123622,i,si,108,edwards sapien 3,9600tfx26,3190
4130339,i,si,63,edwards sapien 3,9600tfx29,3190
4137683,i,si,459,edwards sapien 3,9600tfx23,3190
4139937,i,si,2,edwards sapien 3,9600tfx29,2993
4142716,i,si,41,edwards sapien 3,9600tfx23,3190
4145745,i,si,0,edwards sapien 3,9600tfx23,2993
4145745,i,si,0,edwards sapien 3,9600tfx23,3190
4154965,i,si,2,edwards sapien 3,9600tfx26,2993
4154965,i,si,2,edwards sapien 3,9600tfx26,2993
4160446,i,si,429,edwards sapien 3,9600tfx23,3190
4162238,i,si,140,edwards sapien 3,9600tfx29,3190
4166023,i,si,365,edwards sapien 3,9600tfx29,2993
4184968,i,si,314,edwards sapien 3,9600tfx26,3190
4200467,i,si,409,edwards sapien 3,9600tfx29,3190
4211628,i,si,29,edwards sapien 3,9600tfx23,3190
4211628,i,si,29,edwards sapien 3,9600tfx23,3190
4214448,i,si,59,edwards sapien 3,9600tfx23,3190
4216324,i,si,191,edwards sapien 3,9600tfx26,3190
4216324,i,si,173,edwards sapien 3,9600tfx26,3190
4220620,i,si,246,edwards sapien 3,9600tfx29,3190
4221405,i,si,0,edwards sapien 3,9600tfx26,2993
4228936,i,si,176,edwards sapien 3,9600tfx20,3190
4233898,i,si,365,edwards sapien 3,9600tfx26,3190
4245691,i,si,125,edwards sapien 3,9600tfx20,3190
4248198,i,si,105,edwards sapien 3,9600tfx29,3190
4248532,i,si,298,edwards sapien 3,9600tfx23,3190
4248532,i,si,304,edwards sapien 3,9600tfx23,3190
4248609,i,si,57,edwards sapien 3,9600tfx23,3190
4250458,i,si,409,edwards sapien 3,9600tfx20,3190
4250942,i,si,270,edwards sapien 3,9600tfx23,3190
4259321,i,si,0,edwards sapien 3,9600tfx20,3190
4260862,i,si,361,edwards sapien 3,9600tfx23,3190
4261211,i,si,189,edwards sapien 3,9600tfx26,3190
4261211,i,si,376,edwards sapien 3,9600tfx26,3190
4265189,i,si,324,edwards sapien 3,9600tfx26,3190
4269970,i,si,203,edwards sapien 3,9600tfx23,3190
4279311,i,si,194,edwards sapien 3,9600tfx29,3190
4279311,i,si,186,edwards sapien 3,9600tfx29,3190
4283333,i,si,226,edwards sapien 3,9600tfx26,3190
4283447,i,si,9,edwards sapien 3,9600tfx23,2993
4285246,i,si,11,edwards sapien 3,9600tfx26,2993
4285246,i,si,8,edwards sapien 3,9600tfx26,3190
4291164,i,si,249,edwards sapien 3,9600tfx20,3190
4295118,i,si,352,edwards sapien 3,9600tfx26,3190
4297422,i,si,246,edwards sapien 3,9600tfx23,3190
4307055,i,si,359,edwards sapien 3,9600tfx23,3190
4317721,i,si,120,edwards sapien 3,9600tfx29,3190
4323068,i,si,93,edwards sapien 3,9600tfx23,3190
4328838,i,si,280,edwards sapien 3,9600tfx23,3190
4333728,i,si,331,edwards sapien 3,9600tfx23,3190
4339161,i,si,302,edwards sapien 3,9600tfx23,3190
4339161,i,si,302,edwards sapien 3,9600tfx23,3190
4348483,i,si,96,edwards sapien 3,9600tfx26,2993
4348483,i,si,117,edwards sapien 3,9600tfx26,2993
4348483,i,si,124,edwards sapien 3,9600tfx26,2993
4348483,i,si,278,edwards sapien 3,9600tfx26,2993
4348483,i,si,116,edwards sapien 3,9600tfx26,3190
4350216,i,si,219,edwards sapien 3,9600tfx29,3190
4352244,i,si,167,edwards sapien 3,9600tfx26,3190
4352244,i,si,157,edwards sapien 3,9600tfx26,3190
4356725,i,si,100,edwards sapien 3,9600tfx23,3190
4358977,i,si,197,edwards sapien 3,9600tfx26,3190
4362871,i,si,245,edwards sapien 3,9600tfx29,3190
4365174,i,si,365,edwards sapien 3,9600tfx23,3190
4365727,i,si,317,edwards sapien 3,9600tfx26,3190
4373359,i,si,361,edwards sapien 3,9600tfx23,3190
4373359,i,si,341,edwards sapien 3,9600tfx23,3190
4373847,i,si,71,edwards sapien 3,9600tfx26,2993
4373847,i,si,122,edwards sapien 3,9600tfx26,2993
4374766,i,si,293,edwards sapien 3,9600tfx26,3190
4374766,i,si,367,edwards sapien 3,9600tfx26,3190
4375932,i,si,376,edwards sapien 3,9600tfx23,3190
4402442,i,si,14,edwards sapien 3,9600tfx23,2993
4457589,i,si,0,edwards sapien 3,9600tfx26,2993
4459961,i,si,263,edwards sapien 3,9600tfx29,3190
4459961,i,si,260,edwards sapien 3,9600tfx29,3190
4463243,i,si,170,edwards sapien 3,9600tfx29,3190
4466852,i,si,30,edwards sapien 3,9600tfx23,2993
4477369,i,si,1,edwards sapien 3,9600tfx29,2993
4478271,i,si,8,edwards sapien 3,9600tfx26,2993
4487206,i,si,149,edwards sapien 3,9600tfx26,3190
4552996,i,si,2,edwards sapien 3,9600tfx26,2993
4577278,i,si,1,edwards sapien 3,9600tfx26,2993
4582882,i,si,1,edwards sapien 3,9600tfx26,2993
4582882,i,si,1,edwards sapien 3,9600tfx26,3190
4612711,i,si,1,edwards sapien 3,9600tfx23,2993
4614789,i,si,98,edwards sapien 3,9600tfx26,3190
4614895,i,si,24,edwards sapien 3,9600tfx29,2993
4617565,i,si,9,edwards sapien 3,9600tfx29,2993
4617565,i,si,0,edwards sapien 3,9600tfx29,3190
4622977,i,si,7,edwards sapien 3,9600tfx23,3190
4625243,i,si,1,edwards sapien 3,9600tfx26,2993
4629649,i,si,0,edwards sapien 3,9600tfx23,2993
4629649,i,si,0,edwards sapien 3,9600tfx23,3190
4636487,i,si,0,edwards sapien 3,9600tfx23,2993
4636487,i,si,0,edwards sapien 3,9600tfx23,3190
4637993,i,si,0,edwards sapien 3,9600tfx29,2993
4640114,i,si,6,edwards sapien 3,9600tfx23,2993
4644993,i,si,23,edwards sapien 3,9600tfx26,2993
4646628,i,si,0,edwards sapien 3,9600tfx26,2993
4646628,i,si,0,edwards sapien 3,9600tfx26,2993
4648829,i,si,1,edwards sapien 3,9600tfx26,2993
4649957,i,si,4,edwards sapien 3,9600tfx26,3190
4650287,i,si,0,edwards sapien 3,9600tfx23,3190
4650792,i,si,0,edwards sapien 3,9600tfx26,2993
4652704,i,si,0,edwards sapien 3,9600tfx26,3190
4653367,i,si,5,edwards sapien 3,9600tfx23,2993
4655036,i,si,3,edwards sapien 3,9600tfx29,2993
4656583,i,si,0,edwards sapien 3,9600tfx23,2993
4658198,i,si,0,edwards sapien 3,9600tfx26,2993
4659633,i,si,0,edwards sapien 3,9600tfx23,3190
4660045,i,si,0,edwards sapien 3,9600tfx29,2993
4660507,i,si,7,edwards sapien 3,9600tfx26,2993
4660507,i,si,0,edwards sapien 3,9600tfx26,3190
4661227,i,si,8,edwards sapien 3,9600tfx26,3190
4663661,i,si,0,edwards sapien 3,9600tfx26,2993
4664868,i,si,3,edwards sapien 3,9600tfx23,2993
4665767,i,si,2,edwards sapien 3,9600tfx23,2993
4665767,i,si,2,edwards sapien 3,9600tfx23,3190
4666001,i,si,0,edwards sapien 3,9600tfx26,2993
4666926,i,si,12,edwards sapien 3,9600tfx29,2993
4667595,i,si,0,edwards sapien 3,9600tfx29,2993
4668778,i,si,9,edwards sapien 3,9600tfx29,2993
4672289,i,si,0,edwards sapien 3,9600tfx23,2993
4672329,i,si,2,edwards sapien 3,9600tfx29,2993
4674546,i,si,0,edwards sapien 3,9600tfx26,2993
4674982,i,si,1,edwards sapien 3,9600tfx26,2993
4679171,i,si,7,edwards sapien 3,9600tfx23,3190
4679773,i,si,3,edwards sapien 3,9600tfx26,2993
4694094,i,si,0,edwards sapien 3,9600tfx29,2993
4694634,i,si,4,edwards sapien 3,9600tfx23,3190
4694634,i,si,1,edwards sapien 3,9600tfx23,3190
4694716,i,si,3,edwards sapien 3,9600tfx29,2993
4694758,i,si,0,edwards sapien 3,9600tfx26,2993
4694766,i,si,2,edwards sapien 3,9600tfx26,2993
4696254,i,si,0,edwards sapien 3,9600tfx26,3190
4699868,i,si,2,edwards sapien 3,9600tfx29,2993
4700210,i,si,6,edwards sapien 3,9600tfx23,3190
4700325,i,si,0,edwards sapien 3,9600tfx23,2993
4700325,i,si,0,edwards sapien 3,9600tfx23,2993
4700478,i,si,0,edwards sapien 3,9600tfx23,3190
4700645,i,si,6,edwards sapien 3,9600tfx29,3190
4701901,i,si,10,edwards sapien 3,9600tfx29,3190
4702150,i,si,8,edwards sapien 3,9600tfx23,2993
4702150,i,si,4,edwards sapien 3,9600tfx23,2993
4702809,i,si,0,edwards sapien 3,9600tfx20,3190
4702809,i,si,-27,edwards sapien 3,9600tfx20,2993
4702809,i,si,0,edwards sapien 3,9600tfx20,3190
4702837,i,si,22,edwards sapien 3,9600tfx29,2993
4704441,i,si,0,edwards sapien 3,9600tfx29,2993
4704441,i,si,0,edwards sapien 3,9600tfx29,2993
4704441,i,si,0,edwards sapien 3,9600tfx29,3190
4705773,i,si,0,edwards sapien 3,9600tfx26,2993
4708430,i,si,23,edwards sapien 3,9600tfx29,2993
4711089,i,si,2,edwards sapien 3,9600tfx29,2993
4711624,i,si,31,edwards sapien 3,9600tfx26,2993
4714477,i,si,0,edwards sapien 3,9600tfx23,2993
4714477,i,si,0,edwards sapien 3,9600tfx23,2993
4714725,i,si,1,edwards sapien 3,9600tfx26,2993
4714877,i,si,0,edwards sapien 3,9600tfx26,3190
4714879,i,si,1,edwards sapien 3,9600tfx26,2993
4716331,i,si,6,edwards sapien 3,9600tfx23,3190
4717275,i,si,0,edwards sapien 3,9600tfx26,2993
4717276,i,si,27,edwards sapien 3,9600tfx20,2993
4717468,i,si,3,edwards sapien 3,9600tfx26,2993
4718046,i,si,0,edwards sapien 3,9600tfx26,2993
4720280,i,si,14,edwards sapien 3,9600tfx26,3190
4720469,i,si,0,edwards sapien 3,9600tfx23,2993
4720469,i,si,0,edwards sapien 3,9600tfx23,3190
4720827,i,si,0,edwards sapien 3,9600tfx20,3190
4722224,i,si,3,edwards sapien 3,9600tfx29,2993
4722567,i,si,10,edwards sapien 3,9600tfx20,2993
4723855,i,si,7,edwards sapien 3,9600tfx29,2993
4724465,i,si,7,edwards sapien 3,9600tfx23,2993
4724731,i,si,0,edwards sapien 3,9600tfx26,2993
4725564,i,si,7,edwards sapien 3,9600tfx23,2993
4726177,i,si,2,edwards sapien 3,9600tfx23,3190
4726177,i,si,3,edwards sapien 3,9600tfx23,3190
4726537,i,si,26,edwards sapien 3,9600tfx26,2993
4726556,i,si,23,edwards sapien 3,9600tfx23,3190
4729065,i,si,3,edwards sapien 3,9600tfx26,2993
4729287,i,si,0,edwards sapien 3,9600tfx23,3190
4729491,i,si,3,edwards sapien 3,9600tfx29,2993
4729714,i,si,0,edwards sapien 3,9600tfx29,2993
4729714,i,si,0,edwards sapien 3,9600tfx29,3190
4729770,i,si,16,edwards sapien 3,9600tfx26,2993
4730062,i,si,0,edwards sapien 3,9600tfx23,3190
4732380,i,si,9,edwards sapien 3,9600tfx23,2993
4732588,i,si,7,edwards sapien 3,9600tfx29,2993
4732590,i,si,17,edwards sapien 3,9600tfx23,2993
4732874,i,si,35,edwards sapien 3,9600tfx23,3190
4733677,i,si,4,edwards sapien 3,9600tfx29,2993
4733901,i,si,20,edwards sapien 3,9600tfx23,3190
4734773,i,si,5,edwards sapien 3,9600tfx23,2993
4735333,i,si,1,edwards sapien 3,9600tfx23,2993
4735385,i,si,1,edwards sapien 3,9600tfx23,2993
4735770,i,si,0,edwards sapien 3,9600tfx23,3190
4736604,i,si,4,edwards sapien 3,9600tfx26,2993
4736860,i,si,3,edwards sapien 3,9600tfx29,2993
4736898,i,si,12,edwards sapien 3,9600tfx26,2993
4737701,i,si,4,edwards sapien 3,9600tfx26,2993
4737923,i,si,0,edwards sapien 3,9600tfx23,2993
4737923,i,si,0,edwards sapien 3,9600tfx23,3190
4738771,i,si,4,edwards sapien 3,9600tfx23,3190
4739605,i,si,4,edwards sapien 3,9600tfx26,2993
4739661,i,si,6,edwards sapien 3,9600tfx29,2993
4740264,i,si,1,edwards sapien 3,9600tfx29,2993
4740837,i,si,7,edwards sapien 3,9600tfx29,2993
4740837,i,si,7,edwards sapien 3,9600tfx29,3190
4740884,i,si,2,edwards sapien 3,9600tfx23,2993
4741643,i,si,45,edwards sapien 3,9600tfx23,3190
4741643,i,si,41,edwards sapien 3,9600tfx23,3190
4741976,i,si,1,edwards sapien 3,9600tfx26,2993
4752551,i,si,5,edwards sapien 3,9600tfx29,2993
4752869,i,si,7,edwards sapien 3,9600tfx26,2993
4753098,i,si,7,edwards sapien 3,9600tfx26,3190
4754612,i,si,0,edwards sapien 3,9600tfx29,2993
4756393,i,si,5,edwards sapien 3,9600tfx23,2993
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4794072,i,si,3,edwards sapien 3,9600tfx29,2993
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4835798,i,si,2,edwards sapien 3,9600tfx26,2993
4835891,i,si,1,edwards sapien 3,9600tfx26,2993
4835958,i,si,4,edwards sapien 3,9600tfx26,2993
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4836683,i,si,34,edwards sapien 3,9600tfx23,2993
4836931,i,si,5,edwards sapien 3,9600tfx23,2993
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4836985,i,si,0,edwards sapien 3,9600tfx29,3190
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4837325,i,si,1,edwards sapien 3,9600tfx29,2993
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4837428,i,si,2,edwards sapien 3,9600tfx26,2993
4837436,i,si,0,edwards sapien 3,9600tfx23,3190
4837451,i,si,1,edwards sapien 3,9600tfx23,2993
4837552,i,si,0,edwards sapien 3,9600tfx29,3190
4837648,i,si,4,edwards sapien 3,9600tfx26,2993
4837852,i,si,0,edwards sapien 3,9600tfx26,2993
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4838214,i,si,0,edwards sapien 3,9600tfx26,3190
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4838262,i,si,0,edwards sapien 3,9600tfx26,3190
4838482,i,si,1,edwards sapien 3,9600tfx23,2993
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4838512,i,si,1,edwards sapien 3,9600tfx29,2993
4838573,i,si,2,edwards sapien 3,9600tfx23,2993
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4838727,i,si,0,edwards sapien 3,9600tfx26,3190
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4840596,i,si,2,edwards sapien 3,9600tfx23,2993
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4841621,i,si,2,edwards sapien 3,9600tfx29,2993
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4842380,i,si,2,edwards sapien 3,9600tfx29,3190
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4842831,i,si,0,edwards sapien 3,9600tfx26,3190
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4844067,i,si,0,edwards sapien 3,9600tfx26,3190
4844138,i,si,3,edwards sapien 3,9600tfx29,2993
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4844262,i,si,0,edwards sapien 3,9600tfx23,3190
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4844327,i,si,0,edwards sapien 3,9600tfx26,2993
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4844588,i,si,0,edwards sapien 3,9600tfx26,2993
4844638,i,si,1,edwards sapien 3,9600tfx29,3190
4844709,i,si,0,edwards sapien 3,9600tfx23,3190
4844729,i,si,0,edwards sapien 3,9600tfx20,2993
4844739,i,si,0,edwards sapien 3,9600tfx26,2993
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4844790,i,si,0,edwards sapien 3,9600tfx23,3190
4844850,i,si,7,edwards sapien 3,9600tfx23,2993
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4845211,i,si,1,edwards sapien 3,9600tfx29,2993
4845240,i,si,1,edwards sapien 3,9600tfx23,2993
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4846088,i,si,6,edwards sapien 3,9600tfx26,2993
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4846452,i,si,3,edwards sapien 3,9600tfx26,2993
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4846640,i,si,1,edwards sapien 3,9600tfx26,3190
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4847094,i,si,3,edwards sapien 3,9600tfx29,2993
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4847744,i,si,2,edwards sapien 3,9600tfx29,2993
4847744,i,si,2,edwards sapien 3,9600tfx29,2993
4847744,i,si,23,edwards sapien 3,9600tfx29,2993
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4861030,i,si,5,edwards sapien 3,9600tfx26,3190
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4868022,i,si,2,edwards sapien 3,9600tfx29,2993
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4580546,s,si,336,edwards sapien 3,9600tfx29,3190
4627244,s,si,28,edwards sapien 3,9600tfx23,2993
3659762,s,si,0,edwards sapien 3,9600tfx29,2993
3659762,s,si,0,edwards sapien 3,9600tfx29,3190
3665,s,si,0,edwards sapien 3,9600tfx26,3190
4649147,s,si,0,edwards sapien 3,9600tfx29,3190
4650711,s,si,0,edwards sapien 3,9600tfx26,2993
4724003,s,si,31,edwards sapien 3,9600tfx23,2993
4726790,s,si,0,edwards sapien 3,9600tfx26,2993
4758923,s,si,0,edwards sapien 3,9600tfx29,3190
4759083,s,si,0,edwards sapien 3,9600tfx26,2993
4760857,s,si,37,edwards sapien 3,9600tfx26,3190
4765608,s,si,0,edwards sapien 3,9600tfx29,2993
4765608,s,si,2,edwards sapien 3,9600tfx29,2993
4793620,s,si,7,edwards sapien 3,9600tfx23,2993
4318738,s,si,227,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 LLC
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 Key8172123
MDR Text Key130619087
Report Number2015691-2018-05353
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/17/2018
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/17/2018
Initial Date FDA Received12/17/2018
Was Device Evaluated by Manufacturer? No
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) Required Intervention;
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