MAUDE Adverse Event Report: ABBOTT VASCULAR INC. MITRAL CLIP; MITRAL VALVE REPAIR DEVICE

Model Number NTMSK0103

Device Problem Gas/Air Leak (2946)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 07/10/2018

Event Type  malfunction  

Event Description

During the third clip deployment, the patient's blood pressure dropped and s-t segment was elevated.After deployment, air was noted in the left ventricle by anesthesia via transesophageal echocardiography (tee).

• Brand Name: MITRAL CLIP
• Type of Device: MITRAL VALVE REPAIR DEVICE
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3885 bohannon drive; menlo park CA 94025
• MDR Report Key: 7784451
• MDR Text Key: 117158239
• Report Number: 7784451
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NTMSK0103
• Device Catalogue Number: NTMSK0103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30295 DA