Model Number GELSOFT PLUS STRAIGHT |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Seroma (2069)
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Event Date 09/30/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Once the explanted grafts have been returned and assessed, a full report of the findings / conclusions will be provided.
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Event Description
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Vascutek ltd.Was notified of an event that occurred in (b)(6); the event was described as follows: on the (b)(6) 2009, the patient received x2 vascutek ltd.Manufactured gelsoft plus straight grafts as part of a vascular system repair.Post implant (6.5 years) later the patient had developed a seroma.On (b)(6) 2016 (x2) sections of one of the implanted grafts were explanted and replaced.(this was recorded as comp 3175 - fda ref 9612515-2016-00022).Following this, on the (b)(6) 2016, a third section of the graft(s) was explanted due to a seroma formation.No effusion or infection was identified upon graft extraction.
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Manufacturer Narrative
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(b)(4).Results - no failure detected - physical evaluation, scanning electron microscopy.Evaluation identified no issues, graft structure was in a good state of condition and the fibres were tight and uniform.Qc and manufacturing record review identified no issues with batch manufacture, qc inspection or sterilisation processes.Pathological testing was inconclusive; however initial testing by clinician confirmed no sign of infection or effusion conclusion - unable to confirm the complaint; no failure was detected.Vascutek's occurrence rate for this type of event (seroma) in gelsoft grafts (inclusive of all variants of gelsoft & gelsoft plus vascular grafts) is (b)(4) which is lower than rates stated in the clinical papers.A review of the overall seroma rates shows no adverse trends.From a review of vascutek's clinical evaluation report for polyester vascular grafts and a review of relevant clinical papers, it has been noted that seroma formation is a known and expected complication of this type of procedure.No definitive root cause could be determined for the reported seroma from vascutek's investigation of the returned device.No further actions are required 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 considers this event as closed.
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Event Description
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This report for mfr 9612515-2016-00033 is to provide an update regarding the progress of the investigation.
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Search Alerts/Recalls
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