September 1, 2016 — A woman with broken pieces of a defective Cook Celect® IVC Filter permanently embedded in her heart has filed a lawsuit against Cook Medical.
The lawsuit (PDF) was filed by Joan Wiseman, a woman from California who was implanted with the IVC filter at a hospital in Newport Beach in January 2008.
In September 2015, a CT scan revealed that the filter was defective. The following month, she underwent surgery to remove the filter.
Doctors determined that the Celect had migrated, tilted, and perforated through her right renal vein into her right kidney. Two filter limbs were also fractured. One of the fractured pieces had migrated into her abdomen. The other piece migrated into her heart.
Surgeons removed most of the filter and one of the pieces, but they could not retrieve the piece in her heart. They tried again in November 2015, but were unsuccessful and abandoned attempts to retrieve it.
The lawsuit cites a number of studies in which the Celect could not be removed because it perforated through the vena cava. In one study of 27 patients, all of them had some degree of perforation within 71 days.
The plaintiff has requested a jury trial and seeks compensation in excess of $75,000, according to the North Carolina Record. The lawsuit was filed on August 22 in the U.S. District Court for the Central District of California (Southern Division) — Case No. 8:16-cv-01542.
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