MAUDE Adverse Event Report: VASCUTEK LTD GELSOFT PLUS BIFURCATE

Model Number GELSOFT PLUS BIFURCATE

Device Problems Material Deformation (2976); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2016

Event Type  Injury  

Manufacturer Narrative

Additional information - device samples are en-route to vascutek from the distributor.(b)(4).No information available - no device information (lot, serial no.) has been provided; thus no review of the retained manufacturing and quality records has been completed.Conclusion - device not yet returned; though evaluation is anticipated.

Event Description

Vascutek's distributor in (b)(4) reported that the graft (a gelsoft plus bifurcate vascular prosthesis) was explanted due to continual graft dilation since implant and subsequent graft leakage.The patient displayed no symptoms and suffered no impairment of health as a result.The clinician decided to explant the graft as a preventative measure and the procedure was not classed as an emergency.

Manufacturer Narrative

(b)(4).Evaluation / investigation summary report: no batch review has been performed, as the details that have been provided thus far cannot be traced.The distributor was unable to obtain additional information.The affected product was returned as three individual pieces (samples); they were labelled as #1: right limb, #2: left limb, #3: central side (body).The samples were deep cleaned to facilitate analysis.The initial visual analysis identified no visible damage to the structure of the three samples.Sample 1 (leg) was measured as approx.35mm in length and with a diameter of 11.Mm.Sample 2 (leg) was measured as approx.30mm in length and with a diameter of 11.1mm.Sample 3 (body) was measured as approx.10mm in length.It was noted that sample no.3 was returned cut fully along its length and partially across its diameter; therefore a measurement of the inside diameter could not be taken.The internal diameter specification for a leg component for cat no.632010 device is 10±0.5mm; therefore as both samples measured approx.11mm this shows that the samples diameter has expanded by approx.+0.6mm.Textiles analysis was performed on samples one and two.The analysis indicated that the samples appeared to be in an excellent state of physical condition with no knitting faults.A wale count of 48 on both samples one and two confirms that they are from a leg of a 20 x 10mm graft, possibly catalogue no.632010.The diameter is true for samples 1 & 2, with dilatation of around 8 - 9%.Textiles analysis of sample three indicates that the material appears stretched; however due to the sample size, vascutek was unable to complete a full analysis of the fabric.The three samples were microscopically examined using an sem (scanning electron microscope); this analysis confirmed, there was no visible evidence that indicated any tensile damage to the fibers.It was noted that the weave appeared loose in some areas for sample 3, though the vast majority of the surfaces inspected appeared uniform and intact.From the analysis and investigation performed on the returned sections the graft, although dilated, displayed no signs of damage or distress of the material.A review of clinical papers was undertaken (ref below), and the device ifu, it has been noted that dilatation is a known and expected complication of this type of procedure due to the knitted structure of the graft.The percentage of dilatation varies significantly throughout literature.In the last six years from jan 2011 to dec 2016 vascutek has received a total of (b)(4) complaints, inclusive of this one, where dilatation of the gelsoft branded grafts has been reported as an issue.The no.Of events v's sales for this period and graft type (gelsoft family) provides an incidence rate of (b)(4), which is very low.As dilatation of knitted grafts is an inherent and expected complication there is no common industry incident rate for comparison.Therefore vascutek ltd.Carried out a literature review for dilatation of dacron based knitted grafts; a summary is detailed below.D b nunn et al (1990) stated " dilatation is the most common inherent failure mode of knitted dacron aortic prosthesis.The structural and material properties of vascular grafts are to a large extent responsible for the dilatation problem.Whereas woven fabrics with interlacing yarns have comparatively high initial modulus and exhibit little or no dilatation at low levels of stress, both weft and warp knitted structures behave quite differently.Because of their looped structure, knitted fabrics have little resistance to extension.Consequently, the loops can easily straighten in the line of the highest stress.The initial dilation observed in knitted fabrics, therefore, is due to the straightening of loops and the functional constraints at contact points." in this follow up study of 32 patients previously reported in 1979, ct scanning disclosed that the three parts of each graft dilated.Mean percentage dilation values for the series were ; aortic portion 67% ± 38%sd, right limb 77% ±66%sd, left limb 54% ± 26%sd.Dilatation was found in 100% of the grafts studied.Goeau-brissonniere et al (2000) compared the knitting structure of grafts as to their dilatation on bifurcated grafts and in the koper - knitted grafts there was a dilatation of 44% in the straight with a corresponding 49% in the limbs 8 days post implantation and in the warp -knitted grafts there was a dilatation of 50% in the body with a corresponding 58% in the limbs.Etz et al(2007) found that the smaller the diameter of the graft implanted, the larger the dilatation, and that dilatation of any dacron graft should be expected.The possible adverse events from such rapid dilatation is a possible graft fracture or false aneurysm formation at the anastomosis, though this is considered a rare complication to occur in the early days post implantation and is usually found in grafts that have been in situ for a significant number of years.References: d b nunn et al (1990) postoperative dilation of knitted dacron aortic bifurcation graft- journal of vascular surgery; 1990;12:297-297 etz.C.D.Et al (2007) vascular graft replacement of the ascending and descending aorta : do dacron grafts grow, annals of thoracic surgery;(84) 1206 - 1213.Goeau-brissonniere.O.A (2000) can knitting structure affect silatation of polyester bifurcated prostheses? a randomized study with the use of helical computed tomography scanning; journal of vascular surgery 31(1), 157-158.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.

Event Description

This record is a follow up #1 report regarding mfr 9612515-2016-00034 that was submitted to the fda on december 27th 2016.

• Brand Name: GELSOFT PLUS BIFURCATE
• Type of Device: GELSOFT PLUS BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: carolyn forrest ; newmains avenue; inchinnan business park; glasgow, renfrewshire PA49R-R ; UK PA49RR ; 418125555
• MDR Report Key: 6204515
• MDR Text Key: 63259250
• Report Number: 9612515-2016-00034
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2016,01/24/2017

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
• Device Operator: Health Professional
• Device Model Number: GELSOFT PLUS BIFURCATE
• Device Catalogue Number: 632010P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/28/2016
• Device Age: 14 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2016
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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