Catalog Number 28-B2-30-080S |
Device Problems
Partial Blockage (1065); Fluid/Blood Leak (1250)
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Patient Problems
Pulmonary Embolism (1498); Tachycardia (2095); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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During first evar attempt (directly after incision in right groin) pt.Had an unexpected tachycardia and ended into successful reanimation.Couple of weeks later again evar with extra pacing lead to be safe.Evar went well, with no problems.A small type ii endoleaks presented on the postop angio.Technically no problems.During postop surveillance patient had 4 embolic events (2 in each leg) and extensive blood analyses did not find anything special.Because of these events and more important the patent type ii endoleak on the postop cta explantation of the evar was performed.During explantation 1 or 2 major type ii endoleaks were noticed but also a leakage was seen through the anterior side of the ipsi limp of the main body (type 3 or 4).Explanted device is available for investigation.Patient outcome - "after open surgery patient encountered a pulmonary embolism.".
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Manufacturer Narrative
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This complaint was involved with three devices.Device 2 is being reported under mdr-2247858-2022-00098, and device 3 is being reported under mdr-2247858-2022-00099.
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Event Description
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During first evar attempt (directly after incision in right groin) pt.Had an unexpected tachycardia and ended into successful reanimation.Couple of weeks later again evar with extra pacing lead to be safe.Evar went well, with no problems.A small type ii endoleaks presented on the postop angio.Technically no problems.During postop surveillance patient had 4 embolic events (2 in each leg) and extensive blood analyses did not find anything special.Because of these events and more important the patent type ii endoleak on the postop cta explantation of the evar was performed.During explantation 1 or 2 major type ii endoleaks were noticed but also a leakage was seen through the anterior side of the ipsi limp of the main body (type 3 or 4).Explanted device is available for investigation.Patient outcome - "after open surgery patient encountered a pulmonary embolism.".
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Manufacturer Narrative
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This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2022-00097, device 2 is being reported under mdr-2247858-2022-00098, and device 3 is being reported under mdr-2247858-2022-00099.
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Search Alerts/Recalls
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