Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM Back to Search Results
Catalog Number CDS0201
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 09/29/2017
Event Type  Death  
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.
 
Manufacturer Narrative
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
 
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 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMITRACLIP SYSTEM CLIP DELIVERY SYSTEM
Type of DeviceMITRACLIP DELIVERY SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
MENLO PARK, CA REG# 3005070406
abbott vascular
26531 ynez rd.
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key7211243
MDR Text Key105948724
Report Number2024168-2018-00520
Device Sequence Number1
Product Code NKM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue NumberCDS0201
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/22/2018 Patient Sequence Number: 1
-
-