The complaint artegraft (collagen vascular graft) lot 17g195-007 was not returned to artegraft, inc.For evaluation as it was "repaired" by the surgeon during implant.The patient was reported to be in stable condition.A review of the production batch device history record was performed; no anomalies were identified.All grafts released from product batch 17g195 passed all of the requirements including wall thickness, pressure testing, sterility testing, and final visual inspection prior to final release to finished goods.The customer's allegation was not able to be confirmed as the graft remains implanted.No additional complaints from this product batch were reported to date.No confirmed complaint trend was identified related to thin graft wall and suture hole bleeding.The complaint issue will continue to be monitored within artegraft, inc.Quality systems, quality assurance trending.Should additional information become available, a follow-up report will be submitted.
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Follow-up 001: a portion of the complaint graft (lot: 17g195-007) which was not implanted was returned to artegraft, inc.For evaluation.The calculated wall thickness on each end of the returned graft portion was verified to be within the required product specifications; therefore, the issue was not confirmed.(b)(4).
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