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Model Number SGC0701 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
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Event Date 12/08/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device will not be returned for evaluation, the device was reportedly discarded.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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This is filed due to access site complications.Patient id: (b)(6).It was reported that on (b)(6) 2021, a mitraclip procedure was performed for functional mitral regurgitation (mr), grade 4+.One mitraclip was successfully implanted, reducing the mr to grade 1+.On (b)(6) 2021, the patient presented to an outside emergency department for access site pain and swelling.An acute deep vein thrombosis (dvt) of the femoral vein and a superficial thrombosis of the saphenous vein were observed, secondary to the recent right femoral vein approach for the mitraclip procedure.Medications were provided and the patient was discharged home.No additional information was provided regarding this issue.
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.The reported patient effects of thrombosis, swelling/edema and pain are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Based on available information, a cause for the reported thrombosis could not be determined.The reported pain and swelling appear to be a cascading effect of thrombosis.The reported medication was a result of case-specific circumstances.There is no indication of product issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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