A relatively straightforward surgery had gone terribly wrong and the patient had died on the table. Surgeons were supposed to insert a blood clot filter, where clots from the legs are caught and dissolved before they reach the lungs. But then the patient died. ECRI Institute's Accident Investigation team was hired to find out why. Our experts reviewed medical records and watched X-ray videos from the surgery. The filter, which looks like the ribs of an open umbrella, was correctly positioned in a vein between the heart and the lower body.
The FDA's Manufacturer and User Facility Device Experience database contained previous incidents where the capsule holding the filter detached from the delivery catheter because of contamination at the bonding site. In the case of the patient who died, the detached capsule flowed with the patient's blood into the heart. As the muscles of the heart contracted, the capsule perforated the organ, causing fatal bleeding. Our investigation found a manufacturing defect. Days after the completion of a months-long joint investigation into the case, the manufacturer recalled about 18,000 filters worldwide.
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