It was reported that during the procedure for treating an acute ischemic stroke in the left middle cerebral artery, the stent retriever could not be advanced anymore or withdrawn from inside the subject catheter.The physician withdrew both the stent retriever and subject catheter from inside the patient anatomy as he considered the stent retriever to be damaged.This event resulted in a thirty-minute surgical delay during the procedure and the physician assumed the patient suffered a large area of cerebral infarction and passed into a coma from the surgical delay.There is no direct relationship between the device and the adverse event, but the physician thought that the patient with large area cerebral infarction because of the surgical delay.The procedure was completed successfully with another product.No further information is available.
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The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The returned product was confirmed.During visual inspection, the device was inspected and the catheter shaft was found kinked/bent and flat/crushed.No other anomalies were noted.During functional inspection, the retriever was advanced through this catheter with no friction.The reported defect was not confirmed; however the analysis results are consistent with the event.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.As per the additional information, the patient¿s anatomy was moderately tortuous.The device was returned and the catheter was noted to be kinked and flattened.It is probable that the catheter was damaged during advancement due to the tortuous anatomy causing the reported event.This complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.Therefore, an assignable cause of procedural factors will be assigned to the reported and analyzed event.The reported patient complications and patient stroke are known and anticipated complications to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned.
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It was reported that during the procedure for treating an acute ischemic stroke in the left middle cerebral artery, the stent retriever could not be advanced anymore or withdrawn from inside the subject catheter.The physician withdrew both the stent retriever and subject catheter from inside the patient anatomy as he considered the stent retriever to be damaged.This event resulted in a thirty-minute surgical delay during the procedure and the physician assumed the patient suffered a large area of cerebral infarction and passed into a coma from the surgical delay.There is no direct relationship between the device and the adverse event, but the physician thought that the patient with large area cerebral infarction because of the surgical delay.The procedure was completed successfully with another product.No further information is available.
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