MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number PAC081501

Device Problems Fracture (1260); Obstruction of Flow (2423)

Patient Problems Ischemia (1942); Pain (1994); Phlebitis (2004); Thrombosis (2100); Thrombosis/Thrombus (4440)

Event Date 03/27/2017

Event Type  Injury  

Manufacturer Narrative

The device remains implanted in the patient.

Event Description

The following event information was reported to gore.On (b)(6) 2016, a thrombosed aneurysm (22%) of the saphenous vein was diagnosed.On (b)(6) 2016, an increase of the thrombosed aneurysm (55%) was diagnosed.On (b)(6) 2017, in patient underwent an intravascular procedure where the thrombosed aneurysm of the saphenous vein was treated using a reported gore viabahn® endoprosthesis.On (b)(6) 2017, 12:25 pm, an in-stent thrombosis of the gore viabahn® endoprosthesis occurred, which required a reintervention by local fibrinolysis.On (b)(6) 2017, 05:00 pm, a second in-stent thrombosis of the gore viabahn® endoprosthesis was diagnosed, which again required a reintervention by local fibrinolysis.The patient reported that this imaging demonstrated a stent wire fracture of the gore viabahn® endoprosthesis.In (b)(6) 2017, a phlebitis of the saphenous vein was diagnosed.The patient reported that the stent wire fracture of the gore viabahn® endoprosthesis triggered the phlebitis.On (b)(6) 2019, an open bypass surgery was performed reportedly due to the alleged in-stent thrombosis of the gore viabahn® endoprosthesis.The gore viabahn® endoprosthesis remains implanted.

Manufacturer Narrative

G5: based on the provided lot number it was identified that the device is not a combined product.

Manufacturer Narrative

B5: updated event description because new information was provided within patient medical records disclosed to w.L.Gore and associates.H6-code 4112: patient medical records have been disclosed to w.L.Gore and associates for evaluation.

Event Description

The following was ascertained from medical records provided: a report from an echo doppler ultrasound examination (dus), performed on (b)(6) 2012, provided that there was an aneurysm in the upper part of the right popliteal artery which measured approximately 15 mm to 16 mm in its anteroposterior diameter.The report stated that it extended over 34 mm in length with a circular parietal thickening.According to the records, during follow up, dus examinations showed stability of the right popliteal aneurysm.However, the records provide that an anterior endoluminal thrombus without downstream slowing developed over the years.A report for a follow up dus examination dated (b)(6) 2016, provided that the partially thrombotic aneurysm of the right popliteal artery measured 18.5 mm and thrombosis measured 55%.According to the records, it was concluded that the aneurysm was therefore becoming threatening.It was stated that it could gradually cause destruction of the downstream system and acute ischemia.A report from a computed angiography tomography dated (b)(6) 2016, stated that that ¿the right popliteal artery presents some irregularities in its course, especially above the line, but without true ectasia and especially without an individualized aneurysmal sac¿.It was stated that the images showed ¿satisfactory permeability of the underlying right popliteal artery, and at the tibial level¿.According to the report, all the vascular axes appear permeable without apparent thrombosis.A report from a follow up computed angiography tomography dated (b)(6) 2017, indicated that there was a partially thrombosed aneurysm in the right articular popliteal artery of 18mm in diameter.According to the report, the downstream system was preserved.It was stated that ¿there was no urgency to take care of this lesion¿; however, the patient was reported ¿to be very demanding, rather anxious¿.Reportedly, under these conditions, the physician proposed a percutaneous treatment with a covered stent, via percutaneous access.Reportedly, on (b)(6) 2017, the patient underwent an intravascular procedure where the thrombosed (55%) aneurysm (diameter 18.5 mm) of the right popliteal artery was treated using a gore viabahn® endoprosthesis.Reportedly, the following devices were used during the intravascular procedure: proglide 6f (2.0 mm), abbott vascular, perclose (suture) gore viabahn® endoprosthesis, pac081501, sn(b)(6) (endoprosthesis) armada 35 (6.0 mm x 60 mm x 80 cm), abbott vascular (pta balloon) hydrophile 0.035¿¿ guidewire reportedly, the intravascular procedure was performed under local anesthesia in supine position of the patient.According to the records, an echo-guided direct puncture of the superficial femoral artery was performed to gain access.The records provided that: an 8fr introducer sheath was inserted and preclosure was performed using proglide (abbott vascular).Then a systemic heparinization was performed.The records stated that then an arteriography was performed to locate a short, slightly narrowed stenosis in the lower right popliteal artery, downstream of the articular popliteal aneurysm.According to the records, then they advanced a hydrophile 0.035¿¿ guidewire across the stenosis and inserted an armada pta balloon (abbott vascular).The balloon was inflated at 8 atm for 2 minutes.The records provided that then a gore viabahn® endoprosthesis was advanced to the lesion, implanted and postdilated with the balloon at 15 atm.Reportedly, the angiographic result was perfect.There was no residual stenosis and no leakage of contrast medium.The downstream system was preserved.According to the records, the patient was re-hospitalized from (b)(6) 2017 to (b)(6) 2017.It was stated that this hospitalization was motivated by subacute right leg ischemia related to thrombosis of the gore viabahn® endoprosthesis, diagnosed on (b)(6) 2017.An initial treatment with in situ fibrinolysis was performed.Reportedly, after fibrinolysis it was seen that the gore viabahn® endoprosthesis was ruptured.According to the records provided with the operative report, a re-thrombosis of the gore viabahn® endoprosthesis ¿occurred due to stent fracture¿ on (b)(6) 2017.It was stated that they performed a popliteal desobliteration with a fogarty probe and an in situ fibrinolysis with 200,000 units of urokinase.According to the records, after this they performed a conventional surgery to exclude the aneurysm of right popliteal artery by reversed great saphenous vein bypass surgery.The records provided that dus examination showed a permeable popliteal bypass with acceleration at its origin.The patient was discharged on (b)(6) 2017.Reportedly, the gore viabahn® endoprosthesis remains implanted.It remains unclear if the eptfe of the gore viabahn® endoprosthesis was ruptured, or if a wire fracture occurred.

Manufacturer Narrative

B5: updated event description because date of implant was updated based on provided additional documents.Section d: updated, because lot number was provided d6: updated date of implant.H6-code 3331: the investigation involved the analysis of relevant production records in view of supporting the identification of possible causes for the adverse event.H6-code 213: a review of the manufacturing records indicated the device met pre-release specifications.H6-code 11: further investigation is being conducted.

Event Description

The following event was reported to gore: - on (b)(6), 2016, a thrombosed aneurysm (22%) of the saphenous vein was diagnosed.- on (b)(6), 2016, an increase of the thrombosed aneurysm (55%) was diagnosed.- on (b)(6), 2017, in patient underwent an intravascular procedure where the thrombosed aneurysm of the saphenous vein was treated using a reported gore viabahn® endoprosthesis.- on (b)(6), 2017, 12:25 pm, an in-stent thrombosis of the gore viabahn® endoprosthesis occurred, which required a reintervention by local fibrinolysis.- on (b)(6), 2017, 05:00 pm, a second in-stent thrombosis of the gore viabahn® endoprosthesis was diagnosed, which again required a reintervention by local fibrinolysis.The patient reported that this imaging demonstrated a stent wire fracture of the gore viabahn® endoprosthesis.- in (b)(6) 2017, a phlebitis of the saphenous vein was diagnosed.The patient reported that the stent wire fracture of the gore viabahn® endoprosthesis triggered the phlebitis.- on (b)(6), 2019, an open bypass surgery was performed reportedly due to the alleged in-stent thrombosis of the gore viabahn® endoprosthesis.- the gore viabahn® endoprosthesis remains implanted.

Manufacturer Narrative

H6-code 4112 and 213: dicom images dated (b)(6) 2016, were provided to gore for evaluation.The imaging evaluation summary states the following: - lesion length ~32mm - diameters proximal to the lesion ~ 7.1-7.6mm - diameters distal to the lesion ~ 5.7-7.9mm - lesion max diameter ~ 14.5mm (centerline, avg), 13.7mm (axial) - there appears to be small vessels originating from the lesion.

Manufacturer Narrative

B5: updated event description h6: health effect impact code: 4607 and 4625.

Event Description

The following was ascertained from medical records provided: a report from an echo doppler ultrasound examination (dus), performed on (b)(6), 2012, provided that there was an aneurysm in the upper part of the right popliteal artery which measured approximately 15 mm to 16 mm in its anteroposterior diameter.The report stated that it extended over 34 mm in length with a circular parietal thickening.According to the records, during follow up, dus examinations showed stability of the right popliteal aneurysm.However, the records provide that an anterior endoluminal thrombus without downstream slowing developed over the years.A report for a follow up dus examination dated (b)(6), 2016, provided that the partially thrombotic aneurysm of the right popliteal artery measured 18.5 mm and thrombosis measured 55%.According to the records, it was concluded that the aneurysm was therefore becoming threatening.It was stated that it could gradually cause destruction of the downstream system and acute ischemia.A report from a computed angiography tomography dated (b)(6), 2016, stated that that ¿the right popliteal artery presents some irregularities in its course, especially above the line, but without true ectasia and especially without an individualized aneurysmal sac¿.It was stated that the images showed ¿satisfactory permeability of the underlying right popliteal artery, and at the tibial level¿.According to the report, all the vascular axes appear permeable without apparent thrombosis.A report from a follow up computed angiography tomography dated (b)(6), 2017, indicated that there was a partially thrombosed aneurysm in the right articular popliteal artery of 18mm in diameter.According to the report, the downstream system was preserved.It was stated that ¿there was no urgency to take care of this lesion¿; however, the patient was reported ¿to be very demanding, rather anxious¿.Reportedly, under these conditions, the physician proposed a percutaneous treatment with a covered stent, via percutaneous access.Reportedly, on (b)(6), 2017, the patient underwent an intravascular procedure where the thrombosed (55%) aneurysm (diameter 18.5 mm) of the right popliteal artery was treated using a gore viabahn® endoprosthesis.Reportedly, the following devices were used during the intravascular procedure: - proglide 6f (2.0 mm), abbott vascular, perclose (suture) - gore viabahn® endoprosthesis, pac081501, sn(b)(6) (endoprosthesis) - armada 35 (6.0 mm x 60 mm x 80 cm), abbott vascular (pta balloon) - hydrophile 0.035¿¿ guidewire.Reportedly, the intravascular procedure was performed under local anesthesia in supine position of the patient.According to the records, an echo-guided direct puncture of the superficial femoral artery was performed to gain access.The records provided that: an 8fr introducer sheath was inserted and preclosure was performed using proglide (abbott vascular).Then a systemic heparinization was performed.The records stated that then an arteriography was performed to locate a short, slightly narrowed stenosis in the lower right popliteal artery, downstream of the articular popliteal aneurysm.According to the records, then they advanced a hydrophile 0.035¿¿ guidewire across the stenosis and inserted an armada pta balloon (abbott vascular).The balloon was inflated at 8 atm for 2 minutes.The records provided that then a gore viabahn® endoprosthesis was advanced to the lesion, implanted and postdilated with the balloon at 15 atm.Reportedly, the angiographic result was perfect.There was no residual stenosis and no leakage of contrast medium.The downstream system was preserved.According to the records, the patient was re-hospitalized from (b)(6), 2017 to (b)(6), 2017.It was stated that this hospitalization was motivated by subacute right leg ischemia related to thrombosis of the gore viabahn® endoprosthesis, diagnosed on (b)(6), 2017.An initial treatment with in situ fibrinolysis was performed.Reportedly, after fibrinolysis it was seen that the gore viabahn® endoprosthesis was ruptured.According to the records provided with the operative report, a re-thrombosis of the gore viabahn® endoprosthesis ¿occurred due to stent fracture¿ on (b)(6), 2017.It was stated that they performed a popliteal desobliteration with a fogarty probe and an in situ fibrinolysis with (b)(4) units of urokinase.According to the records, after this they performed a conventional surgery to exclude the aneurysm of right popliteal artery by reversed great saphenous vein bypass surgery.The records provided that dus examination showed a permeable popliteal bypass with acceleration at its origin.The patient was discharged on (b)(6), 2017.Reportedly, the gore viabahn® endoprosthesis remains implanted.It remains unclear if the eptfe of the gore viabahn® endoprosthesis was ruptured, or if a wire fracture occurred.On (b)(6), 2021, it was reported, that experts assessed the patient¿s current status with a permanent disability in the region of 5% (i.E.Low) and pain assessed to severity grade 2 to 3 on a scale of 7.

Manufacturer Narrative

H6-codes 213 and 4315: cause investigation and conclusion the incident description is based on patient history files which were disclosed to gore.A review of the manufacturing records indicated the device met pre-release specifications.Dicom images dated (b)(6) 2016, were provided to gore for evaluation.The imaging evaluation summary states the following: lesion length ~32mm, diameters proximal to the lesion ~ 7.1-7.6mm, diameters distal to the lesion ~ 5.7-7.9mm, lesion max diameter ~ 14.5mm (centerline, avg), 13.7mm (axial), there appears to be small vessels originating from the lesion.The angioscan dated (b)(6) 2017, was available at the time of the assessment only in the form of an incomplete paper printout.However, this examination makes it possible to see the thrombosis of the covered stent, locate the anchor sites of the proximal and distal stent graft and see the patency of the termination of the popliteal artery and the distal bed of the leg muscle.However, it does not make it possible to comment on whether or not there is a fracture of the covered stent frame.It seems quite unlikely to the experts that a possible stent fracture is directly related to the recanalization and thrombolysis procedure of(b)(6) 2017,, and particularly as a consequence of endovascular maneuvers.¿ additional information has not been released to gore.With no additional information provided, gore is unable to perform further investigations of this incident.Neither reported rupture of the gore viabahn® endoprosthesis nor reported stent wire fracture could be confirmed based on the provided patient history files.The cause of the reported failure modes could not be established with the information provided.In the instructions for use the following is stated: warnings: w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications where the endoprosthesis may experience repeated and extreme flexion, such as across the popliteal fossa and the anticubital fossa.Clinical conditions such as excessive bending, tortuosity, and / or repeated and extreme flexion may result in compromised performance or failure of the endoprosthesis.Hazards and adverse events device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: stenosis, thrombosis or occlusion; distal embolism; pain in the absence of infection and device failure.

Event Description

The following was ascertained from medical records provided: a report from an echo doppler ultrasound examination (dus), performed on (b)(6) 2012, provided that there was an aneurysm in the upper part of the right popliteal artery which measured approximately 15 mm to 16 mm in its anteroposterior diameter.The report stated that it extended over 34 mm in length with a circular parietal thickening.According to the records, during follow up, dus examinations showed stability of the right popliteal aneurysm.However, the records provide that an anterior endoluminal thrombus without downstream slowing developed over the years.A report for a follow up dus examination dated (b)(6) 2016, provided that the partially thrombotic aneurysm of the right popliteal artery measured 18.5 mm and thrombosis measured 55%.According to the records, it was concluded that the aneurysm was therefore becoming threatening.It was stated that it could gradually cause destruction of the downstream system and acute ischemia.A report from a computed angiography tomography dated (b)(6) 2016, stated that ¿the right popliteal artery presents some irregularities in its course, especially above the line, but without true ectasia and especially without an individualized aneurysmal sac¿.It was stated that the images showed ¿satisfactory permeability of the underlying right popliteal artery, and at the tibial level¿.According to the report, all the vascular axes appear permeable without apparent thrombosis.A report from a follow up computed angiography tomography dated (b)(6) 2017, indicated that there was a partially thrombosed aneurysm in the right articular popliteal artery of 18mm in diameter.According to the report, the downstream system was preserved.It was stated that ¿there was no urgency to take care of this lesion¿; however, the patient was reported ¿to be very demanding, rather anxious¿.Reportedly, under these conditions, the physician proposed a percutaneous treatment with a covered stent, via percutaneous access.Reportedly, on (b)(6) 2017, the patient underwent an intravascular procedure where the thrombosed (55%) aneurysm (diameter 18.5 mm) of the right popliteal artery was treated using a gore viabahn® endoprosthesis.Reportedly, the following devices were used during the intravascular procedure: proglide 6f (2.0 mm), abbott vascular, perclose (suture) gore viabahn® endoprosthesis, pac081501, sn (b)(6) (endoprosthesis) armada 35 (6.0 mm x 60 mm x 80 cm), abbott vascular (pta balloon) hydrophile 0.035¿¿ guidewire.Reportedly, the intravascular procedure was performed under local anesthesia in supine position of the patient.According to the records, an echo-guided direct puncture of the superficial femoral artery was performed to gain access.The records provided that: an 8fr introducer sheath was inserted and preclosure was performed using proglide (abbott vascular).Then a systemic heparinization was performed.The records stated that then an arteriography was performed to locate a short, slightly narrowed stenosis in the lower right popliteal artery, downstream of the articular popliteal aneurysm.According to the records, then they advanced a hydrophile 0.035¿¿ guidewire across the stenosis and inserted an armada pta balloon (abbott vascular).The balloon was inflated at 8 atm for 2 minutes.The records provided that then a gore viabahn® endoprosthesis was advanced to the lesion, implanted and postdilated with the balloon at 15 atm.Reportedly, the angiographic result was perfect.There was no residual stenosis and no leakage of contrast medium.The downstream system was preserved.According to the records, the patient was re-hospitalized from (b)(6) 2017.It was stated that this hospitalization was motivated by subacute right leg ischemia related to thrombosis of the gore viabahn® endoprosthesis, diagnosed on (b)(6), 2017.An initial treatment with in situ fibrinolysis was performed.Reportedly, after fibrinolysis it was seen that the gore viabahn® endoprosthesis was ruptured.According to the records provided with the operative report, a re-thrombosis of the gore viabahn® endoprosthesis ¿occurred due to stent fracture¿ on (b)(6) 2017.It was stated that they performed a popliteal desobliteration with a fogarty probe and an in situ fibrinolysis with 200,000 units of urokinase.According to the records, after this they performed a conventional surgery to exclude the aneurysm of right popliteal artery by reversed great saphenous vein bypass surgery.The records provided that dus examination showed a permeable popliteal bypass with acceleration at its origin.The patient was discharged on (b)(6) 2017.Reportedly, the gore viabahn® endoprosthesis remains implanted.It remains unclear if the eptfe of the gore viabahn® endoprosthesis was ruptured, or if a wire fracture occurred.On (b)(6) 2021, it was reported, that experts assessed the patient¿s current status with a permanent disability in the region of 5% (i.E.Low) and pain assessed to severity grade 2 to 3 on a scale of 7.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• 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: sibylle staerk ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8970107
• MDR Text Key: 156762564
• Report Number: 2017233-2019-00814
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2019
• Device Catalogue Number: PAC081501
• Device Lot Number: 15440053
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: CONVIDIEN, ABBOTT; CONVIDIEN, ABBOTT
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male