MAUDE Adverse Event Report: ABBOTT LABORATORIES ABBOTT VASCULAR EVALVE MITRACLIP; CLIP DELIVERY SYSTEM

Model Number ITEM # 813651

Device Problems Break (1069); Separation Failure (2547); Activation, Positioning or Separation Problem (2906)

Patient Problems Mitral Regurgitation (1964); Foreign Body In Patient (2687)

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.

• Brand Name: ABBOTT VASCULAR EVALVE MITRACLIP
• Type of Device: CLIP DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT LABORATORIES; menlo park CA
• MDR Report Key: 5344534
• MDR Text Key: 35157888
• Report Number: 5344534
• Device Sequence Number: 1
• Product Code: NKM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ITEM # 813651
• Device Catalogue Number: CDS0201
• Device Lot Number: 50813U109
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/11/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 88