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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM
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AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM Back to Search Results
Catalog Number CDS0201
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Death (1802)
Date of Event 09/29/2017
Type of Reportable Event Death
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event, implant date - estimated.Due to system limitations, the type of report is selected as 30 day although this is a periodic report.Pas1 and pas2 mitraclip post approval study data is reported as a summary per summary reporting exception approval number e2015009.The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
 
Event or Problem Description
Per the requirements of the post approval study 1 (pas1) and pas2, post approval mitraclip studies conducted via the tvt registry, abbott has received data downloaded from the center for medicare and medicaid services (cms) claims database for patients in the studies.The data contained 347 death events.The relationship of the deaths to the mitraclip device cannot be determined based on the data received; therefore, abbott vascular is conservatively reporting these events.The data are reported as a summary report per summary reporting exemption approval number e2015009.
 
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.Additionally, a review of the lot history records could not be conducted, because the lot numbers were not provided.The reported patient effect of death as listed in the mitraclip system electronic instructions for use, is a known possible complication associated with mitraclip procedures.Based on the information reviewed, a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
 
Event or Problem Description
Unique complaint id number,initial or supplement,type of event,tte in days,device brand name,medical device identifier,device codes
336527?2?1_1105538,,d,175,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_1166485,,d,375,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_1183708,,d,497,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_1194557,,d,645,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_1241191,,d,469,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_1247778,,d,819,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_1347777,,d,686,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_1508377,,d,57,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_1670604,,d,649,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_1965801,,d,632,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_2125320,,d,43,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_2355254,,d,939,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_2635385,,d,337,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_2653003,,d,976,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_2792551,,d,582,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_2952211,,d,201,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_2953376,,d,854,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_2961640,,d,418,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_2990557,,d,653,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3019230,,d,84,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3022957,,d,424,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3041298,,d,38,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3043765,,d,799,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3075060,,d,957,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3075444,,d,11,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3075710,,d,121,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3076051,,d,1012,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3077576,,d,465,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3077697,,d,673,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3077713,,d,751,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3078699,,d,878,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3078868,,d,592,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3078905,,d,820,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3078928,,d,895,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3078963,,d,967,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3078971,,d,694,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3079293,,d,1077,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3079434,,d,116,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3082606,,d,762,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3083784,,d,559,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3084039,,d,803,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3084922,,d,174,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3085789,,d,795,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3085832,,d,742,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3086735,,d,235,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3086888,,d,912,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3086923,,d,945,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3087285,,d,126,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3088110,,d,799,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3088246,,d,590,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3088362,,d,611,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3088394,,d,690,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3088941,,d,483,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3090360,,d,31,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3090461,,d,293,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3090787,,d,561,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3091068,,d,510,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3091559,,d,618,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3091577,,d,20,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3091595,,d,926,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3093522,,d,699,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3094155,,d,391,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3094939,,d,216,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3095373,,d,86,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3095453,,d,237,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3095614,,d,901,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3096246,,d,173,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3096349,,d,812,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3096412,,d,871,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3096876,,d,198,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3097252,,d,532,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3097340,,d,333,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3097648,,d,764,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3097673,,d,885,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3097735,,d,832,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3097777,,d,499,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3098044,,d,524,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3098679,,d,385,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3101434,,d,216,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3102047,,d,399,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3102468,,d,1167,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3102799,,d,962,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3104175,,d,691,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3104734,,d,714,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3106543,,d,970,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3106828,,d,947,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3106937,,d,534,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3107384,,d,219,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3107854,,d,535,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3108163,,d,757,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3109303,,d,465,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3109350,,d,771,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3109666,,d,1042,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3111235,,d,251,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3112275,,d,1006,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3112796,,d,498,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3112834,,d,453,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3116793,,d,231,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3117202,,d,805,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3118427,,d,961,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3123619,,d,836,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3127249,,d,586,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3130204,,d,78,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3130398,,d,895,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3131244,,d,677,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3132570,,d,1065,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3135401,,d,427,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3135674,,d,736,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3137912,,d,647,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3139361,,d,496,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3140165,,d,894,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3141787,,d,834,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3141920,,d,409,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3142833,,d,143,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3143662,,d,406,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3146599,,d,82,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3148118,,d,233,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3149850,,d,677,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3153520,,d,203,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3154293,,d,102,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3156609,,d,741,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3157132,,d,382,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3157504,,d,286,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3157588,,d,197,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3158038,,d,112,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3161538,,d,554,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3161871,,d,919,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3161927,,d,300,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3162770,,d,505,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3162902,,d,210,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3164462,,d,506,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3164808,,d,588,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3165090,,d,529,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3167163,,d,614,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3173016,,d,528,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3177986,,d,869,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3178104,,d,852,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3178548,,d,467,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3181844,,d,130,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3181874,,d,598,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3183034,,d,683,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3183342,,d,859,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3186340,,d,685,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3187428,,d,454,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3187669,,d,390,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3188965,,d,522,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3189108,,d,402,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3191730,,d,774,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3193914,,d,556,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3194137,,d,207,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3195206,,d,881,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3198941,,d,724,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3199058,,d,729,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3202391,,d,772,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3204886,,d,744,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3205447,,d,842,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3208414,,d,806,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3208817,,d,866,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3209031,,d,859,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3210651,,d,821,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3210932,,d,578,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3211018,,d,280,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3211311,,d,100,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3211735,,d,786,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3211752,,d,548,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3213036,,d,794,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3213263,,d,534,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3216515,,d,479,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3216664,,d,398,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3216776,,d,68,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3216783,,d,448,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3218087,,d,794,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3218799,,d,407,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3218920,,d,413,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3218957,,d,313,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3223212,,d,722,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3223361,,d,525,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3224519,,d,598,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3226072,,d,104,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3226336,,d,800,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3227958,,d,126,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3228823,,d,535,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3228905,,d,858,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3228944,,d,582,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3229300,,d,100,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3229475,,d,678,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3230027,,d,771,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3231102,,d,61,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3231421,,d,508,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3231739,,d,599,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3232221,,d,265,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3232618,,d,253,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3233033,,d,796,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3233602,,d,527,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3241176,,d,478,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3242221,,d,241,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3243344,,d,553,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3243900,,d,450,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3247243,,d,410,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3248686,,d,404,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3250477,,d,617,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3252456,,d,523,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3253351,,d,251,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3254280,,d,575,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3255470,,d,797,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3260239,,d,147,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3260883,,d,200,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3267534,,d,398,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3270136,,d,700,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3271337,,d,606,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3274551,,d,707,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3275621,,d,242,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3275965,,d,399,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3276704,,d,600,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3277659,,d,665,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3279467,,d,721,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3283337,,d,219,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3283644,,d,813,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3287906,,d,423,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3289622,,d,137,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3291690,,d,768,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3297022,,d,754,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3298516,,d,434,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3299119,,d,711,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3302144,,d,823,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3302992,,d,25,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3303839,,d,7,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3304834,,d,134,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3304934,,d,35,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3305824,,d,240,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3310700,,d,708,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3310833,,d,757,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3312753,,d,725,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3313077,,d,374,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3313340,,d,315,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3314114,,d,757,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3314152,,d,420,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3314333,,d,603,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3315188,,d,12,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3317674,,d,626,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3318560,,d,429,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3318575,,d,85,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3324057,,d,75,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3324999,,d,544,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3325462,,d,678,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3326380,,d,785,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3326981,,d,32,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3327567,,d,91,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3328596,,d,515,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3329326,,d,705,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3330782,,d,784,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3331515,,d,493,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3332285,,d,800,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3332978,,d,282,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3334365,,d,498,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3334543,,d,485,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3336930,,d,472,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3339105,,d,683,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3344248,,d,553,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3344922,,d,612,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3348474,,d,185,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3348504,,d,676,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3348857,,d,204,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3350030,,d,572,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3352437,,d,129,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3353017,,d,573,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3353861,,d,235,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3357885,,d,409,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3358249,,d,684,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3359284,,d,430,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3362375,,d,534,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3363377,,d,180,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3365050,,d,674,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3366995,,d,362,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3372864,,d,524,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3372936,,d,635,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3380351,,d,253,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3381702,,d,438,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3381756,,d,379,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3382996,,d,778,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3383212,,d,513,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3385091,,d,880,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3391456,,d,104,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3392246,,d,503,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3392324,,d,123,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3392349,,d,258,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3394845,,d,784,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3395998,,d,392,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3397147,,d,532,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3398485,,d,610,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3400220,,d,432,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3400846,,d,728,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3404574,,d,929,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3404786,,d,61,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3415297,,d,66,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3415780,,d,482,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3416078,,d,554,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3416198,,d,523,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3417558,,d,232,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3422027,,d,401,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3422917,,d,399,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3426056,,d,784,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3434342,,d,433,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3439978,,d,535,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3440077,,d,55,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3441270,,d,563,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3441456,,d,519,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3442011,,d,666,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3442276,,d,536,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3442558,,d,462,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3442574,,d,737,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3445646,,d,540,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3445767,,d,38,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3446008,,d,599,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3449111,,d,720,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3449262,,d,710,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3453950,,d,454,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3457437,,d,604,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3458094,,d,498,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3461125,,d,580,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3461877,,d,91,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3463201,,d,279,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3463455,,d,589,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3467809,,d,524,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3468211,,d,401,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3477865,,d,574,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3479112,,d,144,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3479184,,d,738,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3479198,,d,86,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3481517,,d,585,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3486465,,d,323,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3487358,,d,56,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3487542,,d,138,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3487552,,d,253,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3487614,,d,641,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3488571,,d,340,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3489131,,d,428,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3490586,,d,294,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3496578,,d,11,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3498059,,d,493,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3498142,,d,203,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3498233,,d,78,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3500317,,d,137,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3501006,,d,342,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3593607,,d,26,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3594268,,d,690,mitraclip system clip delivery system,n/a,2993 no known device problem
336527?2?1_3599295,,d,162,mitraclip system clip delivery system,n/a,2993 no known device problem.
 
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Brand Name
MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
Common Device Name
MITRACLIP DELIVERY SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
MDR Report Key7211243
Report Number2024168-2018-00520
Device Sequence Number1063849
Product Code NKM
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
P100009
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date (Section B) 02/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Health Professional
Device Catalogue NumberCDS0201
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/29/2017
Supplement Date Received by Manufacturer02/12/2018
Initial Report FDA Received Date01/22/2018
Supplement Report FDA Received Date02/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Death;
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