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Model Number SGC0701 |
Device Problem
Difficult to Advance (2920)
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Patient Problems
Hematoma (1884); Hemorrhage/Bleeding (1888); Tissue Damage (2104); Cardiac Tamponade (2226)
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Event Date 01/26/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device was reportedly discarded.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported issue.A review of the compliant history identified no similar incidents reported from this lot.Based on available information, the reported difficult to advance appears to be due to challenging patient anatomy.The reported patient effects of hematoma, hemorrhage, cardiac tamponade, and tissue damage appear to be caused by a combination of challenging patient anatomy and procedural conditions.Additionally, the reported patient effects of hematoma, hemorrhage, cardiac tamponade, and tissue damage are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported additional therapy/non-surgical treatment is the result of case-specific circumstances.There is no indication of product issue with respect to manufacture, design or labeling.
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Event Description
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This is filed to report hematoma, hemorrhage, cardiac tamponade.Intervention, tissue damage.It was reported that this was a mitraclip procedure to treat grade 4 mixed mitral regurgitation (mmr).Noted restricted leaflets, chordal flail.Additionally, the patient had a "peri-atrial cyst" that appeared as a large space in the atrium as well as a very large atrial septal defect (asd) about 2 cm.There was difficulty going transseptal with the steerable guide catheter (sgc) as it kept sliding down to the atrial-septal defect (asd).Once it was able to pass through the asd, the sgc went high and into the cyst area.The clip delivery system was then advanced, and one clip was successfully implanted, reducing mr to 1-2.When the sgc was removed, the cyst area filled with blood and/ or a hematoma likely due to the transseptal puncture going into the cyst/chamber and possibly resulted in cardiac tamponade.Heparin was reversed and the tamponade stopped.The previous asd was unable to be closed so the procedure was aborted, and the patient was sent to the intensive care unit to be monitored.The patient improved and was discharged the next day.No additional information was provided.
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Search Alerts/Recalls
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