MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT PLUS; GELSOFT PLUS GELATIN IMPREGNATED KNITTED VASCULAR PROSTHESIS, PRODUCT

Model Number	GELSOFT PLUS STRAIGHT
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	09/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Once the explanted grafts have been returned and assessed, a full report of the findings / conclusions will be provided.
Event or Problem Description
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.
Additional Manufacturer Narrative
(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.
Event or Problem Description
This report for mfr 9612515-2016-00033 is to provide an update regarding the progress of the investigation.

• Brand Name: GELSOFT PLUS
• Common Device Name: GELSOFT PLUS GELATIN IMPREGNATED KNITTED VASCULAR PROSTHESIS, PRODUCT
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9 RR,; UK PA4 9RR,
• MDR Report Key: 6168739
• Report Number: 9612515-2016-00033
• Device Sequence Number: 16326204
• Product Code: DSY
• UDI-Device Identifier: 05037881115047
• UDI-Public: 05037881115047
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2017
• Report Date (Section F): 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2014
• Device Model Number: GELSOFT PLUS STRAIGHT
• Device Catalogue Number: 636008P
• Device Lot Number: 102152
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/28/2016
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2016
• Supplement Report FDA Received Date: 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention