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

Model Number GELSOFT STRAIGHT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 01/08/2016

Event Type  Injury  

Manufacturer Narrative

Device discarded by hospital - not returned to manufacturer.(b)(4).Unable to confirm complaint - without return of device or sample of serum vascutek was unable to investigate further to confirm complaint.Device not returned - no device was returned for investigation therefore unable to investigate further.A perigraft seroma is a sterile collection of clear fluid with a non-secretory pseudomembrane surrounding a prosthetic vascular graft.The aetiology is unknown but may relate to relative fibroblast inhibition, with failure of graft incorporation into surrounding tissues.Treatments have included observation alone, multiple aspirations, graft removal, injection of perigraft sclerosing agents, excision of the fibrous pseudocapsule, or intraperitoneal drainage.It is clear that the causative factors in peri-graft seroma are unclear.A review of clinical papers related to seroma has been carried out.In a 14 year retrospective study of perigraft seroma by ahn ss et al(1) they observed post operative rates of seroma formation between 0.3% to 4.2% in a mixture of dacron and ptfe grafts.Sera was taken from three patients with perigraft seroma and from five patients with well incorporated grafts and three healthy volunteer subjects and tested for fibroblast inhibition.Only the patients with perigraft seroma exhibited inhibited fibroblast formation.They concluded that perigraft seroma appears to involve a humoral fibroblast inhibitor which prevents maturation and proliferation of perigraft fibroblasts leading to poor incorporation.Wittens et al2 (1992) reported a relatively high level of post-operative seroma formation in up to 25% of patients.The association of seroma with implant location rather than the graft was also shown by blumenberg et al3.(1985).A collection of clear, sterile fluid, confined within a nonsecretory fibrous pseudomembrane surrounding a vascular graft, is a specific clinicopathologic entity termed perigraft seroma.A comprehensive survey, including the entire north american chapter of the international society for cardiovascular surgery membership, provided 279 cases for detailed analysis.Material most commonly involved were knitted dacron (54%) and polytetrafluroethylene (34%), with knitted dacron in the axillofemoral position accounting for 31% of the cases.It is also possible that some abnormality in the healing process allows serum to permeate through the graft wall.Pircolo et al.4 (1991) found that seroma fluid inhibited fibroblast growth.The authors stated that different theories have been postulated in the last 10 years in an attempt to explain the pathogenetic mechanisms involved in perigraft seroma formation.The findings suggested that a perigraft seroma may represent a complex phenomenon which cannot be explained exclusively in terms of fibroblast stimulation or inhibition.Perigraft seroma: clinical, histologic and serologic correlates.Ahn et al, am j surg.1987 aug; 154(2): 173-8.European prospective randomised multi-centre axillio-bifemoral trial.C.H.A.Wittens et al.Eur j vasc surgery 6, 115-123(1992).Perigraft seromas complicating arterial grafts.Blumenberg et al.Surgery st louis vol 97 no.2 pp 194-203(1985).Effect of perigraft seroma fluid on fibroblast proliferation in vitro.V e pricolo et al.Ann vasc surg.1991 sep;5(5):462-6.All 6 events reported from this site are from a variety of products and sizes (gelsoft straights,gelsoft bifurcates, gelsoft plus straights).These batches were manufactured over a period of almost 2 years (aug 2013 - jul-2015) all but two ((b)(4)) used different base material batches.None of the complaint batches were gelatin impregnated on the same date and all were sterilised in different cycles.No further complaints have been reported related to these batches or sterilisation cycles to date.A summary of this information is attached to this report.In conclusion the only commonality in these events is the site reported from.Without the return of the graft for analysis vascutek are unable to determine a definitive root cause of this event however 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.Vascutek's overall occurrence rate for this type of event is (b)(4) which is lower than rates stated in the clinical papers.On this basis vascutek now considers this complaint closed.However this issue will be tracked and trended as part of the routine complaints monitoring and reporting process.If an adverse trend develops actions will be taken at that time.Discarded by hospital.

Event Description

One of six events reported from (b)(6) relating to seroma formation around implanted graft.

• Brand Name: GELSOFT
• Type of Device: GELSOFT GELATIN IMPREGNATED KNITTED VASCULAR PROSTHESIS
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: carolyn forrest ; newmains avenue; inchinnan business park; renfrewshire, scotland PA4 9-RR ; UK PA4 9RR ; 418125555
• MDR Report Key: 5440530
• MDR Text Key: 38284081
• Report Number: 9612515-2016-00006
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K990503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2016,02/17/2016

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?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2020
• Device Model Number: GELSOFT STRAIGHT
• Device Catalogue Number: 634007
• Device Lot Number: 354959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/08/2016
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2016
• Initial Date Manufacturer Received: 01/22/2016
• Initial Date FDA Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR