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

Model Number	CDS0201
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982)
Date of Event	05/12/2017
Type of Reportable Event	Death
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 transcatheter valve therapy - tvt registry data that mitraclip devices may be related to death events.The relationship of the deaths 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.Tvt death summary analysis (b)(4).
Event or Problem Description
It was reported through transcatheter valve therapy (tvt) registry data that mitraclip devices may be related to 20 death events.The relationship of the deaths 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?2?1 ? 3123786?21582? 21961,,d,437,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?2?1 ? 3131990?22065? 21616,,d,995,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?2?1 ? 3141418?22488? 22011,,d,206,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?2?1 ? 3176098?23916? 23415,,d,375,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?2?1 ? 3231088?27641? 27067,,d,298,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?2?1 ? 3303820?32131? 31552,,d,349,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?2?1 ? 3352330?36016? 35390,,d,516,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?2?1 ? 3372768?70274? 69252,,d,767,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?2?1 ? 3376167?36012? 35387,,d,67,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?2?1 ? 3420683?38949? 38264,,d,68,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?2?1 ? 3426228?39348? 38653,,d,372,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?2?1 ? 3467882?41942? 41190,,d,178,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?2?1 ? 3467950?41948? 41195,,d,18,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?2?1 ? 3470561?42106? 41359,,d,454,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?2?1 ? 3483664?42792? 42040,,d,462,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?2?1 ? 3488604?43188? 42433,,d,754,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?2?1 ? 3490640?43361? 42606,,d,625,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?2?1 ? 3491092?44001? 43235,,d,394,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?2?1 ? 3498005?44023? 43255,,d,335,mitraclip system clip delivery system,n/a,2993 ? no known device problem 324241?2?1 ? 3498862?44144? 43380,,d,148,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: 6695458
• Report Number: 2024168-2017-05715
• Device Sequence Number: 1736465
• 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: Death