Catalog Number UNK EMBOSHIELD NAV6 |
Device Problems
Difficult to Remove (1528); Failure to Advance (2524); Activation Failure (3270)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/01/2014 |
Event Type
malfunction
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Manufacturer Narrative
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Age or date of birth: average.Sex: majority.Date of event: estimated.Title: ¿post market clinical follow-up evaluation report abbott carotid stent and embolic protection systems¿.The device(s) are not returning.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The udi is unknown as the specific part/lot number(s) are unknown.The additional patient effects and abbott devices, along with device issues, referenced in article, are captured under separate medwatch report numbers.
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Event Description
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The post-market clinical follow-up (pmcf) report, titled ¿post market clinical follow-up evaluation report abbott carotid stent and embolic protection systems¿ evaluated the safety and performance of the rx acculink and x.Act carotid stent system (css) and the emboshield nav 6 and rx accunet embolic protection system (eps).It was reported through the pmcf report that the emboshield nav 6 may be related to unsuccessful placement.Although the above events were noted, in conclusion, the overall analyses from this study demonstrates that the use of the emboshield nav 6 met the safety and performance criteria.This pmcf reports the abbott devices are similar to competitor devices and are within state-of-art.The abbott devices have comparable safety and performance issues when using versus competitor devices.The overall residual risk of device use is acceptable.Specific patient information is documented as unknown.Details are listed in pmcf report titled ¿post market clinical follow-up evaluation report abbott carotid stent and embolic protection systems¿.
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Manufacturer Narrative
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A2: average.A3, a5b: majority.B3, estimated.D4: the udi# is unknown because the part and lot numbers were not provided.D4 and h4: the device expiration and manufacturing dates could not be provided as the device lot number was not provided and the device was not returned.The device was not returned for evaluation.A review of the lot history record and similar incident query of the reported lot could not be conducted because the part and lot number were not provided.The investigation determined a conclusive cause for the reported failure to advance, activation failure and difficult to remove cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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