Penditure LAA Exclusion System

Description of Event or Problem

Medtronic received information that during use of a Penditure clip device in a Minimally Invasive Cardiac Surgery(MICS), it was reported that when the left atrial appendage was lifted with forceps and clipped, the left atrial appendage tissue was fragile, and bleeding from the forceps site was suspected.Since the base of the left atrial appendage had been clipped, it was considered that bleeding would stop once hemostasis was achieved, however, the clip was recaptured and repositioned, and hemostatic efforts were continued for about one hour. However, the bleeding point was difficult to visualize and the bleeding could not be controlled. The approach was unavoidably converted to a Median Sternotomy, and the clip was recaptured and repositioned; however, bleeding from the upper portion of the left atrial appendage did not subside, so the bleeding point was sutured and the surgery was completed. It was unknown whether the clip had insufficient grasping force, whether the tissue was thick or folded, or whether the tissue had become stiff due to prior catheter ablation. Although the exact cause was unknown, blood inflow into the left atrial appendage was observed even after clipping. Bleeding from the injured site itself was not particularly large; however, since bleeding from the upper portion of the left atrial appendage persisted after clipping, it was considered that blood was still flowing into the appendage. The bleeding site was repaired, and it was determined that the left atrial appendage would eventually thrombose and not cause any issues, so the surgery was concluded. No problems were observed in the patient after the repair. The device was used to complete the procedure. No further adverse effects were reported.

Additional Manufacturer Narrative

Medtronic submits this report to comply with FDA regulations 21 CFR Parts 4 and 803. Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by FDA, Medtronic, or its employees that the device, Medtronic, or its employee caused or contributed to the event described in the report. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. Medtronic will submit a supplemental report if additional relevant information becomes known.