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

Model Number GELWEAVE

Device Problem Infusion or Flow Problem (2964)

Patient Problems Death (1802); Hematoma (1884); Hemorrhage/Bleeding (1888); Ischemia (1942); Respiratory Distress (2045); Thrombosis (2100)

Event Date 01/15/2020

Event Type  Death  

Manufacturer Narrative

Manufacturer narrative: exact date of implant as yet unconfirmed.(b)(4).Analysis of production records: a review of qc, manufacturing and physical test records was carried out and show the batch was manufactured to design specification and met all in process and bass material physical test acceptance criteria.Historical data analysis: a 5-year similar event review was performed on death related to gelweave product: this gave an occurrence rate of 0.003% (complaints v sales).Device not accessible for testing.The device was not explanted, and patient has since died.No device problem found.No issue was found with the manufacture of this batch on review of production records.Conclusion not yet available.Vascutek is endeavouring to gather further information on this event and will report findings in next follow up /final report.

Event Description

On the 26-mar-20 vascutek ltd.Received the following information from our distributor (terumo (b)(4)): patient underwent procedure for open abdominal aortic aneurysm and aorto-bi-iliac bypass and reimplantation bilateral renal arteries (exact date unknown at this time) the additional narrative on the event is as follows: "the patient died on (b)(6) 2020: his condition was complicated during the night of (b)(6) 2020 with ischemia of the right lower limb and thrombosis of the right renal artery which justifies a first surgical reintervention on (b)(6) 2020 for thrombectomy right renal and bilateral external iliac, right renal bypass with prosthesis, bilateral iliofemoral bypasses with prosthesis, angioplasty stenting of the right superficial femoral artery and placement of jj probe in the left ureter.During the night of (b)(6) 2020, the patient presented a hemorrhagic shock related to a hematoma of the right psoas.It then progresses to mesenteric ischemia and ards.Death on (b)(6) 2020.".

Event Description

Additional information received on (b)(6) 2019: 69-year-old patient, without cardiovascular risk factors or major history, followed for several years for a suprarenal aneurysm of the abdominal aorta, evolutive with 8mm growth in 12 months in 2019, maximum diameter measured at 63mm.Scheduled surgery.Asa score 3 atcds: ischemic heart disease stented in 2008, with recent normal scintigraphy patient scheduled for supra-renal aaa open surgery (aorto-bi-iliac bypass).Dorsal decubitus installation.By left retro-peritoneal route, supra-celiac clamping.Cooling of the left kidney by infusion of frozen serum.Endarterectomy of the visceral aorta.Placement of the prosthesis and end-to-end anastomosis under the superior mesenteric artery (ams), with reimplantation of the two renal arteries.Common right and left terminal termino iliac anastomoses.Coeliac and ams clamping time 46 minutes, right renal clamping 53 min, left renal clamping 86 minutes.No particular technical difficulties.In the follow-up, standard hospitalization in intensive care unit, extubation within a few hours.On d1, onset of acidosis with peak lactates at 8.At the same time, ischemia of the right lower limb.An emergency ct scan is performed and found a complete thrombosis of the prosthesis (body and 2 legs), and of the right renal artery.In addition, the intra-prosthetic thrombus has migrated to the level of the two common femoral arteries, resulting in bilateral acute ischemia more severe on the right side.Acute renal failure.Anuria.Surgical re-intervention at d1.Bypass thrombectomy and realisation of a right aorto-renal bypass.Placement of a jj catheter in the left ureter.Post-operative control scanner: permeable prosthesis, the kidneys are homogeneously raised.On the other hand, failure to raise the colon with a ct scan in favor of ischemic colitis.D2: hemorrhagic shock on psoas hematoma.Arterial lactates elevating.Abdominal pain and rectal bleedings.A new ct scan is performed, diffuse superior mesenteric artery, causing ischemic colitis.Hemodynamically unstable patient, major vasopressor support and massive filling.Waiting for stabilization for surgical management d3: recto-sigmoidoscopy which finds a necrotic recto-colitis in connection with a probable ischemic origin.Lactates at 7.8.D4: surgical procedure by digestive surgeons for left colectomy without restoration of continuity.Acute respiratory distress syndrome (ards) on possible inhalation with the need for abdominal decubitus sessions.Thereafter, persistence of major hemodynamic instability.Extension of mesenteric ischemia to the small intestine with no possibility of extensive resection.Ards of unfavorable evolution.Persistence of an organic anuric ari.The therapeutic prospects are exhausted, collegial decision not to re-operate the patient if the deterioration continues.Death reported on d5 after surgery in total, a cascade of major events starting from the early thrombosis of the aorto-bi-biliac prosthesis, without triggering factor.Unexplained prosthetic thrombosis following a scheduled surgery, resulting in: hemorrhagic shock, organic ari with anuria, re-intervention, ards, major hemodynamic instability, extensive mesenteric ischemia and death.Resuscitation measures without therapeutic limitation.Orotracheal intubation.Dialysis.Ventral decubitus.Massive filling and repeated transfusion.Important vasopressor support.Antibiotic therapy.Death.

Manufacturer Narrative

Manufacturers narrative: section h6.Method code 4112 - analysis of data provided by user - a review of additional data provided by hospital was reviewed by vascutek ltd.Clinical risk department, findings are as follows: we are unable to make any clinical comment, especially on the patient will very little information.It is unclear if it's just a coincidence that all three patients (reported from france) required intervention for thrombosis so close together as it is known that it can happen with specific comorbidities/not properly anti-coagulated etc.In regards to this patient.They died from hemorrhagic shock related to a hematoma of the right psoas leading to mesenteric ischemia and ards.It is unclear if this was linked to the thrombosis event.It is more likely that patient comorbidities may have played a part although this can also happen spontaneously.It is also possible that an event which occurred during the procedure could have led to the patent death however no issues were reported.Result code - 213 - no device issue was found with the manufacture of this batch and no definitive link with the patient death could be established.Conclusion code - 67 - no problem detected - as no device or diagnostic scans were received and no issue was found with manufacture of batch no root cause could be established.Conclusion code - 4315 - cause not established - patient death believed to be due to hemorrhagic shock related to a hematoma of the right psoas leading to mesenteric ischemia and ards, it is unclear however if this was linked to the thrombosis event.

• 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: 9989505
• MDR Text Key: 188645131
• Report Number: 9612515-2020-00004
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 05037881107660
• UDI-Public: 05037881107660
• 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

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: GELWEAVE
• Device Catalogue Number: 732211XL55
• Device Lot Number: 17758286 - 2105
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/09/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2020
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR