MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® VIABAHN® ENDOPROSTHESIS; NIP

Catalog Number PAHR061502E

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Occlusion (1984); Sepsis (2067); Multiple Organ Failure (3261)

Event Date 03/09/2017

Event Type  Death  

Manufacturer Narrative

(b)(4)., (b)(4).The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® viabahn® endoprosthesis instructions for use (ifu) in europe, the gore® viabahn® endoprosthesis with propaten bioactive surface is a flexible, self-expanding endoluminal prosthesis for endovascular grafting of peripheral arteries.The gore® viabahn® endoprosthesis with propaten bioactive surface is also indicated for improving blood flow in symptomatic obstructions of peripheral veins.The european ifu states: 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.The european ifu also states: 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.The european ifu also states: w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis with propaten bioactive surface in applications other than the endovascular grafting of peripheral arteries and improving blood flow in symptomatic obstructions of peripheral veins.

Event Description

It was reported to gore that on (b)(6) 2017, a patient underwent a chimney procedure using a combination of gore, endologix, and aneuryx devices.It was reported two gore® viabahn® endoprostheses with heparin bioactive surface were introduced via brachial artery approach and implanted in the celiac trunk and superior mesenteric artery (sma).A conformable gore® tag® thoracic endoprosthesis was also reportedly implanted from a distal approach.It was reported two atrium v12 stents were implanted into both renal arteries, with two endologix nellix® endovascular aneurysm sealing systems also implanted using a distal access.The patient¿s pre-operative condition was reported to be ¿good after a [conventional] surgical tube prosthesis for a juxta renal aneurysm in 2000 to treat: false aneurysm on both anastomosis [sites].¿ it was reported that on (b)(6) 2017, the patient expired.The cause of death was reported to be ¿multi-organ failure (mostly liver), sepsis (after occlusion of [viabahns] and right renal v12.10 hours after the first successful [procedure], the patient underwent a double bypass procedure to her sma and celiac trunk.But too much damage to stent occlusions.¿ the specific allegations related to the gore devices were reported to be occlusion of both viabahn devices.There was no report of an allegation related to the tag device.Additional information, including medical records detailing the implant procedure and the patient's post-operative course, images, and the availability of the viabahn devices for evaluation have been requested from the physician.

Manufacturer Narrative

(b)(4).According to the gore® viabahn® endoprosthesis instructions for use (ifu) in (b)(6), the gore® viabahn® endoprosthesis with propaten bioactive surface is a flexible, self-expanding endoluminal prosthesis for endovascular grafting of peripheral arteries.The gore® viabahn® endoprosthesis with propaten bioactive surface is also indicated for improving blood flow in symptomatic obstructions of peripheral veins.The (b)(6) ifu states: 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.The (b)(6) ifu also states: 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.The (b)(6) ifu also states: w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis with propaten bioactive surface in applications other than the endovascular grafting of peripheral arteries and improving blood flow in symptomatic obstructions of peripheral veins.The (b)(6) ifu indicates the following contraindication: "do not use the gore® viabahn® endoprosthesis with propaten bioactive surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (hit) type ii." the (b)(6) ifu also provides the following warning: "do not use the gore® viabahn® endoprosthesis with propaten bioactive surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of hit type ii.There is no data to demonstrate that the gore® viabahn® endoprosthesis with propaten bioactive surface causes, or contributes to, the condition of hit.The incidence of hit type ii is extremely low in vascular bypass patients receiving heparin over a period of several days.If hit type ii is diagnosed, established procedures for the treatment of this condition, including immediate cessation of systemic heparin administration, should be followed.If symptoms persist, or the health of the patient appears compromised, alternative pharmaceutical or surgical procedures, including removal of the endoprosthesis, may be considered at the discretion of the attending physician.".

Manufacturer Narrative

Corrected event date.Updated event description information.Conclusion code remains unchanged as investigation is ongoing.According to the gore® viabahn® endoprosthesis instructions for use (ifu) in europe, the gore® viabahn® endoprosthesis with propaten bioactive surface is a flexible, self-expanding endoluminal prosthesis for endovascular grafting of peripheral arteries.The gore® viabahn® endoprosthesis with propaten bioactive surface is also indicated for improving blood flow in symptomatic obstructions of peripheral veins.The european ifu states: 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.The european ifu also states: 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.The european ifu also states: w.L.Gore and associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis with propaten bioactive surface in applications other than the endovascular grafting of peripheral arteries and improving blood flow in symptomatic obstructions of peripheral veins.The european ifu indicates the following contraindication: "do not use the gore® viabahn® endoprosthesis with propaten bioactive surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (hit) type ii." the european ifu also provides the following warning: "do not use the gore® viabahn® endoprosthesis with propaten bioactive surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of hit type ii.There is no data to demonstrate that the gore® viabahn® endoprosthesis with propaten bioactive surface causes, or contributes to, the condition of hit.The incidence of hit type ii is extremely low in vascular bypass patients receiving heparin over a period of several days.If hit type ii is diagnosed, established procedures for the treatment of this condition, including immediate cessation of systemic heparin administration, should be followed.If symptoms persist, or the health of the patient appears compromised, alternative pharmaceutical or surgical procedures, including removal of the endoprosthesis, may be considered at the discretion of the attending physician.".

Event Description

It was reported to gore that on (b)(6) 2017, a patient underwent a chimney procedure using a combination of gore, endologix, and aneuryx devices to treat a false aneurysm.It was reported two gore® viabahn® endoprostheses with heparin bioactive surface were introduced via brachial artery approach and implanted in the celiac trunk and superior mesenteric artery (sma).A conformable gore® tag® thoracic endoprosthesis was also reportedly implanted from a distal approach.It was reported two atrium v12 stents were implanted into both renal arteries, with two endologix nellix® endovascular aneurysm sealing systems also implanted using a distal access.It was also reported the two gore® viabahn® endoprostheses with heparin bioactive surface were ballooned after implant, and post implant angiography showed a good result with the devices.Operative records detailing the (b)(6) 2017 procedure were requested but deemed unavailable for release to gore.Based on the information currently available, it is unknown how the gore devices were implanted in relation to the non-gore devices and what devices were in contact with the viabahn devices.It is also unknown how far the viabahn devices were implanted in the sma and celiac arteries.The condition and characteristics of the patient¿s anatomy in which the viabahn devices were implanted is also unknown.The patient¿s pre-operative condition was reported to be ¿good after a [conventional] surgical tube prosthesis for a juxta renal aneurysm in 2000 to treat: false aneurysm on both anastomosis [sites].¿ it was reported the patient did not have a pre-existing infection.Post-operatively on (b)(6) 2017, occlusion of the two gore® viabahn® endoprostheses with heparin bioactive surface was identified.The cause of the occlusion is reportedly unknown.It was reported there was no tortuosity or excessive calcification noted in the areas where the viabahn devices were implanted.It was also reported it is unknown if the patient had a clotting disorder or hypercoagulability issue, but it was reportedly possible the patient presented with heparin induced thrombocytopenia.Medical records detailing the patient¿s post-operative course were requested but deemed unavailable for release to gore.Additionally, images showing the post-implant occlusion of the viabahn devices were requested but also deemed unavailable for release to gore.There is no current information to assess the post-implant condition or placement of the viabahn devices.It was reported that on (b)(6) 2017, the patient expired.The cause of death was reported to be ¿multi-organ failure (mostly liver), sepsis (after occlusion of [viabahns] and right renal v12.Ten (10) hours after the first successful [procedure], the patient underwent a double bypass procedure to her sma and celiac trunk.¿ however, it was further reported that the patient¿s ¿¿condition was poor due to the stent occlusion.¿ there was no report of an allegation related to the tag device.Medical records detailing the patient's post-operative course from (b)(6) 2017 were requested but deemed unavailable for release to gore.Additionally, the availability of the viabahn devices for evaluation by gore was requested, but the devices were reported to be unavailable for evaluation.Additional information is being requested.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: claire west ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7025797
• MDR Text Key: 91881914
• Report Number: 2017233-2017-00590
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Catalogue Number: PAHR061502E
• Device Lot Number: 15815492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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; Hospitalization; Required Intervention
• Patient Age: 56 YR