DLP PERICARDIAL SUMP

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.

Description of Event or Problem

IT WAS REPORTED THAT DURING A VALVE SURGERY AND BYPASS PROCEDURE, A DLP PERICARDIAL SUMP CANNULA FAILED WHEN THE INTEGRATED WIRE BASKET BECAME DEFORMED DURING USE. IT WAS FURTHER REPORTED THAT THIS DEFORMATION WAS ASSOCIATED WITH A TRAUMATIC INJURY TO THE HEART, AND THE DEVICE COULD NO LONGER BE USED FOR ITS INTENDED PURPOSE AND WAS CONSIDERED TO POSE A SIGNIFICANT RISK TO THE PATIENT.