(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the steerable guide catheter was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The clip delivery system is filed under a separate medwatch reports.
|
This is filed to report the thrombus and atrial septal defect.It was reported that prior to the mitraclip procedure to treat grade 4+ degenerative mitral regurgitation (mr), an impella heart pump and a non-abbott catheter were in the patient.The non-abbott catheter was removed and the steerable guiding catheter (sgc), was inserted.After the sgc was inserted, blood clots were observed in the right atrium and heparin was given.The clip delivery system (cds) was advanced to the mitral valve; however, while steering the cds to the mitral valve with the m-knob, the cds went lateral instead of medial.The cds was removed without issue and the blue alignment markers appeared to be misaligned by about 90 degrees.A new cds was used.One clip was implanted reducing mr to 1+.Upon removal of the sgc, an atrial septal defect was noted and was treated with a closure device.A pulmonary angiogram was performed noting that the blood clots had dissipated, so no additional treatment was performed.It is the physicians opinion that the thrombus was related to the non-abbott catheter that was removed prior to the sgc being inserted; however, the sgc may have pushed the clot into the right atrium.The patient remained stable.No additional information was provided.
|
(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.The reported patient effects of emboli (thrombus) and atrial septal defect requiring intervention (atrial perforation), are listed in the mitraclip system instructions for use, as known possible complications associated with mitraclip procedures.A definitive cause for the thrombus and atrial perforation could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|