MAUDE Adverse Event Report: VASCUTEK LTD. GELSOFT PLUS; GELSOFT PLUS BIFURCATE

Model Number GELSOFT PLUS BIFURCATE

Device Problems Partial Blockage (1065); Stretched (1601); Material Twisted/Bent (2981); Insufficient Information (3190)

Patient Problems Pain (1994); Obstruction/Occlusion (2422)

Event Date 01/23/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturer narrative: clinical code: 2422 - obstruction/occlusion: claudication reported as caused by graft dilation 16/8 - 22/11 and kinking of the left and right side.Impact code: 4624 - surgical intervention: surgical intervention: an endovascular thrombectomy of the external and common right iliac artery was performed using the rotarex system.During this procedure a bleeding occurred at the level of the external iliac artery on the right side.As such a stent-graft was implanted (vbx - gore).The stenotic proximal anastomosis was treated with a medtronic iliac limb graft 16/24mm (prestenotic aortic diameter - 12 mm.Stenosis 5mm.Graft posstenosis 22mm).During this procedure the left renal artery was partially occluded and required a stent implantation.The left graft iliac limb was treated because of the kinking through the implantation of an advanta stent 12/41mm.Medical device problem: 3190 - insufficient information: a/w additional information and scans form site.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: a 5 year review of similar complaints (gelsoft sales from jan 19 to feb 24 vs gelsoft occlusion ( claudication ) jan 19 to feb 24 complaints) gave an occurrence rate of (b)(4)% 4111 - communication interview: additional information.3331 - analysis of production records: full batch review performed which showed no issues with the device during manufacture from raw material to finished products.4114 - device not returned: device remains implanted.

Event Description

Event reported from panther post market study as claudication : graft dilatation from 16/8 to 22/11, limb occlusion on the right side, limb dilatation and kinking on the left side.Claudication pain in right thigh after 500 meters, limb occlusion on the right side.Graft dilatation from 16/8 to 22/11, limb dilatation and kinking on the left side.Admitted to hospital (b)(6) 2024, discharged (b)(6) 2024.

Manufacturer Narrative

Manufacturer narrative: clinical code: 2422 - obstruction/occlusion: claudication reported as caused by graft dilation (b)(6) and kinking of the left and right side.1994 - pain - claudication pain.Impact code: 4625 - surgical intervention: surgical intervention: an endovascular thrombectomy of the external and common right iliac artery was performed using the rotarex system.During this procedure a bleeding occurred at the level of the external iliac artery on the right side.As such a stent-graft was implanted (vbx - gore).The stenotic proximal anastomosis was treated with a medtronic iliac limb graft 16/24mm (prestenotic aortic diameter - 12 mm.Stenosis 5mm.Graft posstenosis 22mm).During this procedure the left renal artery was partially occluded and required a stent implantation.The left graft iliac limb was treated because of the kinking through the implantation of an advanta stent 12/41mm.4614 - medical intervention - claudication / occlusion which required medical intervention.Medical device problem: 2981 - ct imaging showed kinking.2423 - obstruction of flow : occlusion reported 1601 - stretched - ct scans showed dilation of the graft.Component code: 4755 - part/component/sub-assembly term not applicable type of investigation: 4110 - trend analysis: a 5 year review of similar complaints (gelsoft sales from jan 19 to feb 24 vs gelsoft occlusion ( claudication ) jan 19 to feb 24 complaints) gave an occurrence rate of 0.011%.4111 - communication interview: additional information.3331 - analysis of production records: full batch review performed which showed no issues with the device during manufacture from raw material to finished products.4114 - device not returned: device remains implanted.Investigation findings:- 213 - no device problem found - review of the retained manufacturing records show the graft was manufactured to specification.Investigation findings:- 4315 - cause not established - no causal link between the device and the event could be determined.

Event Description

This report is being submitted as follow up #1 for mfg report #9612515-2024-00016 to provide event closure information for comp no (b)(4).

• Brand Name: GELSOFT PLUS
• 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: jason whittle ; newmains avenue; inchinnan business park; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 18968206
• MDR Text Key: 338484193
• Report Number: 9612515-2024-00016
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Model Number: GELSOFT PLUS BIFURCATE
• Device Catalogue Number: 631608P50-G
• Device Lot Number: 21600940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/17/2020
• 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: 53 YR
• Patient Sex: Female