• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES ABBOTT VASCULAR EVALVE MITRACLIP CLIP 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
 

ABBOTT LABORATORIES ABBOTT VASCULAR EVALVE MITRACLIP CLIP DELIVERY SYSTEM Back to Search Results
Model Number ITEM # 813651
Device Problems Break; Separation Failure ; Activation, Positioning or Separation Problem
Event Date 12/11/2015
Event Type  Injury  
Event Description

The mitraclip delivery system was advanced into the left atrium and with guidance of multiplane tee, the mitraclip was oriented appropriately over the mitral valve. The clip was then opened and the arms were positioned perpendicularly to the leaflets using the en face 3d tee projection. Once properly oriented, the clip was advanced to the left ventricle, and the clip delivery system was then pulled back and the leaflets were grasped by dropping the grippers. After confirmation of adequate grasping of the leaflets, the arms were closed and reduction of mitral regurgitation was assessed and iatrogenic mitral stenosis was ruled out with direct echocardiographic visualization. Once the 1sr clip was appropriately positioned, standard maneuvers to release the clip were performed, however, the clip would not release from the clip delivery system. Despite multiple maneuvers and after extensive discussion with the company's engineers and representatives, it was determined that one of the device release cables fractured and final deployment of the clip from the delivery system would not be possible. Cv surgeon was consulted and the patient's procedure was converted to open heart surgery to retrieve the retained wire. Postoperatively the patient was admitted to icu. The patient was discharged home on (b)(6) 2015. Referenced to mfr # 2024168-2016-00012.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameABBOTT VASCULAR EVALVE MITRACLIP
Type of DeviceCLIP DELIVERY SYSTEM
Manufacturer (Section D)
ABBOTT LABORATORIES
menlo park CA
MDR Report Key5344534
Report Number5344534
Device Sequence Number1
Product CodeNKM
Report Source User Facility
Reporter Occupation RISK MANAGER
Report Date 12/23/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/05/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberITEM # 813651
Device Catalogue NumberCDS0201
Device LOT Number50813U109
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/11/2015
Event Location Hospital
Date Report TO Manufacturer12/12/2015
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/05/2016 Patient Sequence Number: 1
-
-