MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; GELWEAVE EXTRA LONG BIFURCATE

Model Number GELWEAVE

Device Problem Infusion or Flow Problem (2964)

Patient Problem Thrombosis (2100)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

Patient sex unknown however box checked in error.It is unconfirmed what date this device was implanted.(b)(4).

Event Description

On the (b)(6) 2020 vascutek ltd.Received the following information from our distributor (b)(6): patient underwent surgery for retro-peritoneal approach - bypass aorto-bi-femoral prosthesis with htpogastric reimplantation and hypogastric dilitation and stenting, the additional narrative on this event was reported as follows: "in the night following the surgical intervention, the patient suddenly presented with pain in the right lower limb, without any associated sensory-motor deficit.Surgical revision was performed: the leg prosthesis is well patent but presented an in situ popliteal thrombosis.".

Manufacturer Narrative

Manufacturer narrative: method code - 4112 - analysis of data provided by user - a review of additional data provided by the hospital was reviewed by vascutek ltd.Clinical risk depratment, findings are as follows: this patient has a diagnosis of dyslipidaemia which is an abnormal amount of lipids (e.G.Triglycerides, cholesterol and/or fat phospholipids) in the blood.This is often due to diet and lifestyle.He is also diagnosed with high blood pressure, both of these conditions could cause thrombosis during and post op.It is common to develop thrombus both during and post op even without any co morbidities.This patient developed several during the procedure however there is no mention of this being caused in or around the device.It does confirm that heparin was used however we don't know how much was used at the beginning of the procedure and if the dosage was increased when thrombus appeared.Result code -213 - no device issue was found with the manufacture of this batch and no definitive link with the formation of thrombus could be determined.Conclusion code - 67 - no problem detected - as no device or diagnostic scans were recieved and no issue was found with manufacture of batch no root cause could be established conclusion code - 4315 - cause not established - definitive root cause of the thrombus formation could not be established from the information received and no device was returned for investigation as remains implanted in patient.

Event Description

Further information received 27-apr-20: a 60-year-old man hospitalised in our service for peripheral artery disease, rutherford 4 on the left lower limb and 3 on the right side.Past medical history: prosthetic femoral-femoral cross-bypass (date unknown), replaced by a new fem-fem bypass (date unknown), eventually replaced by a cryopreserved veinous graft.The patient kept symptomatic, so we decided to revascularize with an aorto- bi-femoral bypass.Cardio-vascular risk factors: hbp, dyslipidemia, no diabetes, no active smoking.During the procedure, three episodes of acute thrombosis occurred without any trigger.Multiple thrombectomies were needed to restore blood flow, followed by continuous intravenous heparin perfusion, checked by regular heparinemia rates between 0.2 and 0.4.The day after the surgery, he presented with an acute ischemia to the right lower limb, once again without trigger, treated successfully with fogarty thrombectomy.The thrombophilia test was normal.A chest and abdominal ct-scan failed to uncover any other disease.Eventually, the patient, after being discharged at day-10, came back at day-27 with false aneurysm to the right groin, obviously septic, without any sign of thrombus.

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE EXTRA LONG BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 9989514
• MDR Text Key: 192063920
• Report Number: 9612515-2020-00005
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881107622
• UDI-Public: 05037881107622
• Combination Product (y/n): N
• PMA/PMN Number: K952293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/26/2020,04/30/2020

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 Expiration Date: 06/30/2022
• Device Model Number: GELWEAVE
• Device Catalogue Number: 731407XL55
• Device Lot Number: 17882606 2448
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/04/2020
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2020
• Initial Date Manufacturer Received: 03/26/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR