MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP; MITRAL VALVE REPAIR DEVICES

Model Number CDS0201

Device Problem Positioning Problem (3009)

Patient Problem Laceration(s) (1946)

Event Date 10/23/2015

Event Type  Death  

Event Description

During delivery of 2nd mitraclip device, the clip became entangled in the left atrial appendage.Attempted release of the clip resulted in left atrial appendage laceration that required emergency open heart surgery.Manufacturer response for clip delivery system, mitraclip, clip delivery system, mitraclip (per site reporter): the vendor is aware of the incident as the rep is here for all cases.

• Brand Name: MITRACLIP
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591
• MDR Report Key: 5243503
• MDR Text Key: 31938119
• Report Number: 5243503
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/19/2015

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?: No
• Device Operator: No Information
• Device Model Number: CDS0201
• Device Catalogue Number: CDS0201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR