MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Model Number BXA077902A

Device Problem Complete Blockage (1094)

Patient Problems Renal Failure (2041); Thrombosis/Thrombus (4440)

Event Date 04/24/2023

Event Type  Death  

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H3: all gore® viabahn® vbx balloon expandable endoprostheses (vbx devices) remain implanted.Therefore, direct product analysis was not possible.H6 - code c19: two vbx devices were implanted in an overlapped fashion as one unit.It is unknown if one or both devices occluded.Therefore, one mdr is being submitted for the two devices implanted in right renal artery.Second vbx device lot/serial number is (b)(4); catalog number bxa073902a; udi (b)(4).Review of device manufacturing record history confirmed both devices met pre-release specifications.A total of three manufacturing reports are submitted for same onset date of ae in patient.Additional vbx devices were implanted during index procedure in patient: (1) right renal artery and (2) left renal artery (report #2017233-2023-03911) (3) sma (report #2017233-2023-03909).Ifu for gore® viabahn® vbx balloon expandable endoprosthesis hazards and adverse events procedure related: as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: access site infection; entry site bleeding and/or hematoma; vessel thrombosis, occlusion, pseudoaneurysm, and trauma to the vessel wall (including rupture or dissection); distal embolization; arteriovenous fistula formation; transient or permanent contrast induced renal failure; renal toxicity; sepsis; shock; radiation injury; myocardial infarction; fever; pain; malposition; malapposition; inflammation; and/or death.Device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: hematoma; stenosis, thrombosis or occlusion; distal embolism; side branch occlusion; vessel wall trauma and/or rupture; false aneurysm; infection; inflammation; fever and/or pain in the absence of infection; deployment failure; migration; and device failure.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

The following was reported to gore from a study: on (b)(6) 2020, a patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm in the gore® excluder® thoracoabdominal branch endoprosthesis (tambe) clinical trial.Gore® viabahn® vbx balloon expandable endoprostheses (vbx device) were implanted as side branches in the patient's superior mesenteric artery (sma), celiac artery, plus the renal arteries (left and right).On (b)(6) 2023, patient presented with acute mesenteric ischemia and bilateral renal artery occlusion.As reported, treatment was required.The type of treatment rendered was not specified.

Event Description

On (b)(6) 2023, the patient arrived about 10am with abdominal pain, nausea, and vomiting after eating food.Ct revealed occlusion of sma, bilateral renal stents and associated infarction of the spleen and bilateral kidneys.Vascular surgeon was unavailable at the first facility, so patient was referred to another facility.At second facility the patient already had at least 12 hours of warm ischemia time for both kidneys and was not making urine.The patient was given dilaudid®.Patient continued to have pain and with cta findings, urgent exploration was scheduled.The patient was informed if viable bowel is found, a bypass will be done, then a second exploration and hemodialysis would be necessary.As reported, patient had been experiencing severe muscle pain over the last several weeks, leading to cessation of his statin and prednisone therapy.He was also taken off plavix.Cardiologist notes stated aortic stenosis was somewhat significant, with ejection fraction of 60%.In (b)(6) 2023, patient had a ct angiogram of the tambe device and all four branch devices to the sma, celiac and bilateral renal arteries were patent at that time.On (b)(6) 2023, exploratory laparotomy and bypass procedure were done.A foley was placed and there was about 40 or 50 cc of dark yellow urine.The bowel was dusky and not moving but appeared to be viable with no transmural necrosis observed.Pulse was observed in both external iliac arteries to the pelvis, but no pulse in the sma.The sma was located and found to be patent at this location.The tambe stent graft went into the distal common iliac arteries and the descending thoracic aorta, precluding common iliac origin and a supra celiac origin of the bypass.The left iliac artery was difficult to access due to sigmoid mesentery.An arteriotomy was made at the external iliac origin, and a 6mm hemashield dacron graft was sewn end to side.The dacron graft was then routed to the sma and sewn into place.Peristalsis of the bowel almost began immediately, and there was excellent pulse in the sma.Most of the bowel looked normal with perfusion, except for three areas.One was about 20 cm distal to the ligament of treitz; the ileum and mid jejunum had a few dusky areas but appeared okay.The retroperitoneum was closed over the graft with the omentum intercalated and tacked down to prevent internal hernia.After the fascia was closed, and the skin was stapled.Under ultrasound guidance, a trialysis double-lumen hemodialysis catheter was positioned within the superior vena cava.The procedure was completed with the patient in critical but stable condition.On (b)(6) 2023, a second look and reopening of laparotomy was done to rule out ongoing mesenteric ischemia.There was no evidence of ongoing mesenteric ischemia.After re-opening the fascia, the bowel and entire gi tract appeared viable and pink, except for a single area at the ligament of treitz.The bowel wall had some mild red ecchymotic appearance, related to mobilization of area during the bypass procedure.The bowel was confirmed to be well perfused.The fascia was re-closed with skin stapling.A prevena¿ vac was applied.Patient tolerated procedure well.On (b)(6) 2023, the patient expired.The patient reportedly had a history of depression and mood disorder.Psychiatrist worked with the patient during evaluation on (b)(6) after patient requested a change his code status to dnr and refused hemodialysis.The patient understood hemodialysis complications could happen and chose to proceed with withdrawing hemodialysis and dnr.

Manufacturer Narrative

H1 - changed to death as it was determined gore devices may have contributed to patient's death.

Manufacturer Narrative

H6 - clinical and impact codes were updated based on obtained event information.

Event Description

On (b)(6) 2023, the patient arrived about 10am with abdominal pain, nausea, and vomiting.Ct revealed occlusion of sma and bilateral renal stents.Vascular surgeon was unavailable, requiring patient to transfer to another facility.Upon arrival by 10pm, the patient had about 12 hours of warm ischemia time for both kidneys and was not making urine.The patient was given dilaudid®.Patient continued to have pain and with cta findings, urgent exploration was immediately scheduled.The patient was informed if viable bowel is found, a bypass will be done, and a second look will be necessary.Hemodialysis was also needed.As reported, patient had been experiencing severe muscle pain over the last several weeks, leading to cessation of his statin and prednisone therapy.He was also taken off plavix.Cardiologist notes stated aortic stenosis was somewhat significant, with ejection fraction of 60%.In march 2023, patient had a ct angiogram of the tambe device and all four branch devices to the sma, celiac and bilateral renal arteries were patent at that time.On (b)(6) 2023, exploratory laparotomy and bypass procedure were done.A foley was placed and there was about 40 or 50 cc of dark yellow urine.The bowel was dusky and not moving but appeared to be viable with no transmural necrosis observed.Pulse was observed in both external iliac arteries to the pelvis, but no pulse in the sma.The sma was located and found to be patent at this location.The tambe stent graft went into the distal common iliac arteries and the descending thoracic aorta, precluding common iliac origin and a supra celiac origin of the bypass.The left iliac artery was difficult to access due to sigmoid mesentery.An arteriotomy was made at the external iliac origin, and a 6mm hemashield dacron graft was sewn end to side.The dacron graft was then routed to the sma and sewn into place.Peristalsis of the bowel almost began immediately, and there was excellent pulse in the sma.Most of the bowel looked normal with perfusion, except for three areas.One was about 20 cm distal to the ligament of treitz; the ileum and mid jejunum had a few dusky areas but appeared okay.The retroperitoneum was closed over the graft with the omentum intercalated and tacked down to prevent internal hernia.After the fascia was closed, and the skin was stapled.Under ultrasound guidance, a trialysis double-lumen hemodialysis catheter was positioned within the superior vena cava.The procedure was completed with the patient in critical but stable condition.On (b)(6) 2023, a second look and reopening of laparotomy was done to rule out ongoing mesenteric ischemia.There was no evidence of ongoing mesenteric ischemia.After re-opening the fascia with ease, the bowel and entire gi tract looked viable and pink.Only a single area at the ligament of treitz at the bowel wall had some mild red ecchymotic appearance, which was likely related to mobilization of area during the bypass procedure.The bowel was confirmed to be well perfused.The fascia was re-closed with skin stapling.A prevena¿ vac was applied.Patient tolerated procedure well.On (b)(6) 2023, the patient expired.The patient reportedly had a history of depression and mood disorder.Psychiatrist worked with the patient during evaluation on may 6 after patient requested a change his code status to dnr and refused hemodialysis.The patient understood hemodialysis complications could happen and chose to proceed with withdrawing hemodialysis and dnr.

Manufacturer Narrative

A total of three manufacturing reports are submitted for patient with same ae onset date.A total of six (6) vbx devices were implanted during index procedure in patient: (1) right renal artery and (2) left renal artery, and (3) sma.See also: manufacturer report # 2017233-2023-03909 manufacturer report # 2017233-2023-03911 a4: patient weight was updated based on new information.B4 - b7: event description was updated with new information.Patient medical history was updated with new information.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16873446
• MDR Text Key: 314614125
• Report Number: 2017233-2023-03912
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637539
• UDI-Public: 00733132637539
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Model Number: BXA077902A
• Device Catalogue Number: BXA077902A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2020
• 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): Death; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White