(b)(4).Method: actual device not evaluated - the device was not returned to vascutek as it remains implanted within the patient.No testing method performed - device remained in situ, therefore no further testing occurred.Manufacturing review - a complete review of the manufacturing and qc records was carried out.No issues were identified with the manufacture of the device.Sterilisation review - a review of the sterilisation records was carried out and this confirmed that all acceptance criteria were met for sterilisation.Results: no failure detected - no issues with the device could be identified from the investigation carried out by vascutek.No results available since no device returned - without the return of the device it is not possible to identify a root cause of this event.Conclusion: unable to confirm complaint - no issue with the device could be identified from the investigation carried out by vascutek.Device not returned - without the return of the device it is not possible to identify the root cause of this event.An investigation was completed which showed no issues or adverse trends.A review of manufacturing and qc records confirmed that the device was manufactured to the required specification.Porosity test results for the whole batch of 7 were well below the maximum porosity limit of 77 ml/min.A 5-year review of similar complaints that covered all knitted grafts gave a low occurrence rate of (b)(4) (complaints v sales).There have been no similar complaints from other units of the same batch (7 units in batch).As the device remains in situ within the patient a physical analysis is not possible.The root cause of the event was not identified.Further action is not planned; however, the issue will be tracked and trended as part of the routine complaints monitoring and reporting process.If an adverse trend develops action may be taken at that time.Vascutek consider this case closed.
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