Elation™ 00884450398944Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450398944), received between Aug 27, 2024 and Aug 27, 2024 — classified as 1 death.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT DURING A ROUTINE TRACHEOBRONCHIAL POLYURETHANE STENT FOLLOW-UP APPOINTMENT FOR A FEMALE CANCER PATIENT CURRENTLY RECEIVING PALLIATIVE CARE DUE TO CANCER, THE PHYSICIAN NOTED SOME NARROWING AND WITH MINOR GRANULATED TISSUE PRESENT AT THE STENT SITE. THE STENT WAS PLACED FOR A CANCER-RELATED STRICTURE APPROXIMATELY TWO WEEKS AGO WITHOUT ISSUE. THE PATIENT RECEIVED ONE TREATMENT OF RADIATION THERAPY POST-STENT IMPLANT ON AN UNKNOWN DATE. THE INTERVENTIONAL PULMONOLOGIST RECOMMENDED REMOVING THE EXISTING STENT AND UPSIZING IT TO A LARGER STENT FOR THE PATIENT. DURING THE STENT REMOVAL PROCEDURE, A PULMONARY BALLOON DILATATION CATHETER WAS USED TO DILATE THE INNER DIAMETER OF THE STENT UNDER FLUOROSCOPIC GUIDANCE AND AN ATTEMPT TO REMOVE THE STENT WITH A PAIR OF RAPTOR FORCEPS WAS INITIATED SUCCESSFULLY. THE ACTUAL STENT REMOVAL PROCESS WAS UNREMARKABLE. SOON AFTER THE STENT WAS REMOVED BLEEDING WAS NOTED AT THE STENT SITE. SUCTION WAS ATTEMPTED BUT UNSUCCESSFUL IN CONTROLLING THE HEMORRHAGING. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND A CODE BLUE WAS INITIATED. LIFE-SAVING PROTOCOLS WERE ATTEMPTED FOR THIS PATIENT WITH NO SUCCESS. THE PATIENT DIED IN THE
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20077133 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.