According to pmcf data, an account alleges that while retrieving a stent, from the peripheral vasculature, of an adult female, the patient experienced - stroke, myocardial infarction, and vessel perforation; however, no additional treatment were required.No additional details available.
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The suspect device was not returned for investigation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be re-opened.
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