MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM CLIP DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM

Model Number	CDS0201
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Hemorrhage/Blood Loss/Bleeding (1888); Mitral Regurgitation (1964); Heart Failure (2206); No Information (3190); No Code Available (3191)
Date of Event	05/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Due to system limitations, the type of report is selected as 30-day although this is a periodic report.It was reported through tvt registry data that mitraclip devices may be related to adverse events.The relationship of the adverse events to the mitraclip devices could not be determined based on the data received from the registry.Tvt registry data is reported as a summary per summary reporting exemption approval number - e2015009.
Event or Problem Description
It was reported through the transcatheter valve therapy (tvt) registry data that mitraclip devices may be related to 63 adverse events which are considered serious injuries.The relationship of the adverse events to the mitraclip device could not be determined based on the data received from the registry.Tvt registry data is reported as a summary per summary reporting exemption approval number - e2015009.
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 324241?1?1 ? 3172061?23801? 23309,,si,752,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3209119?44009? 43240,,si,349,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3266506? 113657?112139,,si,844,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3303820?32131? 31552,,si,35,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3312940? 101602?100162,,si,712,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3333930?82193? 81035,,si,650,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3364899?45305? 44531,,si,370,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3389118?36799? 36152,,si,530,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3397642?37412? 36745,,si,490,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3420186?38907? 38220,,si,469,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3434754?39933? 39220,,si,398,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3464923?41755? 41003,,si,484,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3488604?43188? 42433,,si,411,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3494833?43827? 43068,,si,242,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3496071?43900? 43136,,si,376,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3497496?43982? 43217,,si,391,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3498704?44113? 43348,,si,368,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3498764?44122? 43367,,si,346,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3499573?44221? 43458,,si,350,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3176098?23916? 23415,,si,273,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3306551?35736? 35118,,si,137,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3328559?33199? 32593,,si,0,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3339480?34157? 33564,,si,227,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3339480?34157? 33564,,si,65,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3339480?34157? 33564,,si,225,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3339542?34161? 33580,,si,0,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3339542?34161? 33580,,si,0,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3410234?38226? 37551,,si,7,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3410313?64528? 63534,,si,311,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3416024?39216? 38536,,si,65,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3416024?39216? 38536,,si,65,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3420683?38949? 38264,,si,59,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3141418?22488? 22011,,si,175,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3147928?82209? 81053,,si,723,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3260124? 113671?112158,,si,769,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3359170?35066? 34457,,si,0,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3364899?45305? 44531,,si,132,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3365466?35389? 34776,,si,356,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3393671? 116227?114717,,si,814,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3393671? 116227?114717,,si,821,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3393671? 116227?114717,,si,813,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3428341?39494? 38793,,si,140,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3428341?39494? 38793,,si,188,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3437739?40129? 39422,,si,42,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3437739?40129? 39422,,si,33,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3438602?40186? 39469,,si,138,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3438602?40186? 39469,,si,95,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3453792?41081? 40367,,si,196,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3453792?41081? 40367,,si,196,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3454413?41125? 40404,,si,559,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3464527?41728? 40970,,si,64,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3471741?42167? 41417,,si,105,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3472693?42221? 41472,,si,316,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3483712?42796? 42043,,si,342,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3490293?43322? 42569,,si,157,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3491092?44001? 43235,,si,153,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3494833?43827? 43068,,si,154,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3496071?43900? 43136,,si,180,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3496071?43900? 43136,,si,191,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3498097?44033? 43265,,si,143,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3498437?44076? 43311,,si,143,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3498764?44122? 43367,,si,359,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?1?1 ? 3499573?44221? 43458,,si,281,mitraclip system clip delivery system,n/a,2993 ? no known device problem.

• 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 Key: 6695461
• Report Number: 2024168-2017-05714
• Device Sequence Number: 1973313
• Product Code: NKM
• UDI-Device Identifier: 08717648195914
• UDI-Public: (01)08717648195914
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2017

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 Model Number: CDS0201
• Device Catalogue Number: CDS0201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2017
• Initial Report FDA Received Date: 07/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention; Disability