MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number PLC121000

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2019

Event Type  malfunction  

Event Description

On unknown date (pre-2019) the patient was implanted with bilateral kissing stents (manufacturer unknown) in the common iliac arteries and a stent in the external iliac artery.On unknown date the patient presented with a symptomatic penetrating infrarenal aortic ulcer showing a local leak and heavily diseased left and right internal iliac arteries which were not patent.Therefore, on (b)(6) 2019, the patient underwent an endovascular aortic repair with gore® excluder® aaa endoprostheses.Gore® dryseal flex introducer sheaths were used to implant all devices.Reportedly, the physician had trouble deploying the gore® excluder® aaa endoprosthesis stent graft contralateral leg (plc121000 device) used as a contralateral extension of the main body endoprosthesis.They provided post-operative notes where it is stated, that due to unexplained reasons, the plc121000 device did not deploy and was removed from the patient unopened.Reportedly, the plc121000 device was removed together with the gore® dryseal flex introducer sheath in a tandem.They used another plc121000 device to successful complete the procedure.Completion angiography demonstrated a good result, no endoleak, and patent renal and iliac arteries bilaterally.The patient was re-scanned every year with on abnormalities or issues found.When the patient was re-scanned in (b)(6) 2021 the reviewing physician realized that an apparent olive tip from a gore stent graft remained in the patient.It was reported that they think that it was the initial plc121000 device where the olive has come off.

Manufacturer Narrative

B3: updated description health effect - clinical code 4582 was removed from section h6.H6-code 4112: corrected imaging evaluation: dicom images have been provided by the physician.The imaging evaluation summary states the following: five time-points available for evaluation: intra-operative angiogram dated (b)(6) 2019, post-implantation cta dated (b)(6) 2019, abdomen x-rays dated (b)(6) 2019, (b)(6) 2020, and (b)(6) 2021.Intra-operative angiogram dated (b)(6) 2019 appears to show: at 11:22 there appears to be a sheath, guide wire and pigtail catheter advanced from probable right femoral access.At 11:28 there is a non-deployed device present.Non-gore stent(s) can be seen in the iliac arteries, bilaterally.At 11:38 the gore® excluder® endoprosthesis trunk appears to be deployed.The ipsilateral limb on the patient¿s right side appears to be constrained.At 11:45 there appears to be an olive that appears to be attached to the deployment catheter.At 11:48 the ipsilateral leg appears to be deployed on the patient¿s right side.At 11:54 there appears to be a partially deployed device near the left femoral access.(left external iliac artery at the level of the left femoral head.) cannot confirm if this device is being pulled back/removed with the still image provided.At 12:11 there appears to be a deployed contra lateral leg on the left side of the patient, by the radiopaque markers.Ballooning of implanted devices at 12:11, 12:12, and 12:14.12:15:06 there appears to be a probable deployment catheter, a pigtail catheter and 2 sheaths present on the image.12:15:39 the deployment catheter appears to be pulled out through access on the right side of the patient and the sheath appears to be pulled back.There also appears to be a radiopaque density present, in the ipsilateral limb on the right side, that did not appear on the image at 12:15:06.12:16:19 on the final angiogram run provided for evaluation, the radiopaque density remains in the implanted device(s) on the patient¿s right side.There appears to be a density of unknown origin at the level of the proximal device markers of the device trunk.Probable broken delivery catheter and separated olive proximally.There appears to be flow throughout the implanted devices.Post-implantation cta dated (b)(6) 2019 appears to show: images appear to show occlusion of the right internal iliac artery.There appears to be calcium within the riia.Flow in the left internal iliac artery appears to be restored on this time-point.There appears to be a gap, of approximately 4 cm, between the distal end of the contralateral limb in the lci to the proximal end of the stent in the distal lci and the left external iliac artery.There appears to be lack of stent apposition in the distal lci.There appears to be a density of unknown origin in the distal lci.Possible separated olive.Abdomen xray dated (b)(6) 2019 appears to show: a density of unknown origin appears to be on the patient¿s left side at the level of the proximal stent in the distal lci and left external iliac artery.Abdomen xray dated (b)(6) 2020 appears to show: the density of unknown origin appears to be on the patient¿s left side at the level of the proximal stent in the distal lci and left external iliac artery.Abdomen xray¿s dated (b)(6) 2021 appears to show: o the density of unknown origin appears to remain on the patient¿s left side at the same location as the abdomen x-ray¿s on (b)(6) 2020 and (b)(6) 2019.

Event Description

On unknown date (pre-2019) the patient was implanted with bilateral kissing stents (manufacturer unknown) in the common iliac arteries and a stent in the external iliac artery.On unknown date the patient presented with a symptomatic penetrating infrarenal aortic ulcer showing a local leak and heavily diseased left and right internal iliac arteries which were not patent.Therefore, on (b)(6) 2019, the patient underwent an endovascular aortic repair with gore® excluder® aaa endoprostheses.Gore® dryseal flex introducer sheaths were used to implant all devices.Reportedly, the physician had trouble deploying the gore® excluder® aaa endoprosthesis stent graft contralateral leg (plc121000 device) used as a contralateral extension of the main body endoprosthesis.They provided post-operative notes where it is stated, that due to unexplained reasons, the plc121000 device did not deploy and was removed from the patient unopened.Reportedly, the plc121000 device was removed together with the gore® dryseal flex introducer sheath in a tandem.They used another plc121000 device to successful complete the procedure.Completion angiography demonstrated a good result, no endoleak, and patent renal and iliac arteries bilaterally.The patient was re-scanned every year with on abnormalities or issues found.When the patient was re-scanned on (b)(6) 2021, the reviewing physician realized that an apparent olive tip from a gore stent graft remained in the patient.It was reported that they think that it was the initial plc121000 device where the olive has come off.It was reported that the patient remains asymptomatic and is doing well.No reintervention will be performed.

Manufacturer Narrative

H6-code 4115: the delivery system was discarded at the facility.H6-code 213: dicom imaging series provided by the physician have been evaluated.The imaging evaluation summary states that following: seven time-points were available for evaluation: post-implantation cta dated (b)(6) 2015, head/chest cta dated (b)(6) 2019, intra-operative angiogram dated (b)(6) 2019, post-implantation cta dated (b)(6) 2019, abdomen x-rays dated (b)(6) 2019, (b)(6) 2020, and (b)(6) 2021.¿ post-implantation cta dated (b)(6) 2015 appears to show: o the left internal iliac artery appears to be occluded.O there appears to be an excluder device and 2 contralateral limbs implanted.O one of the contralateral limb¿s appears to extend distal from the ipsilateral limb on the right side of the patient.(confirmed through radiopaque markers).O there appears to be devices implanted from the contralateral gate to within the proximal left external iliac artery.The devices appear to cover the left internal iliac artery.O there appears to be a possible density of unknown origin in the descending thoracic aorta at the proximal end of this cta scan.¿ neck cta dated (b)(6) 2019: o there appears to be a density of unknown origin in the distal thoracic aortic arch into the descending thoracic aorta.Mpr image suggests it may be a deployment catheter and olive that appear to be attached to each other with projection provided.O the length from the lsa to the density of unknown origin appears to be ~4.4cm.O the length of the density visualized to the end of the scan appears to be ~4.3cm.O axial images from two different scan dates ((b)(6) 2015 and (b)(6) 2019) appear to have densities of unknown origin within the descending thoracic aorta.¿ intra-operative angiogram dated (b)(6) 2019 appears to show: o at 11:22 there appears to be a sheath, guide wire and pigtail catheter advanced from probable right femoral access.O at 11:28 there is a non-deployed device present.O non-gore stent(s) can be seen in the iliac arteries, bilaterally.O at 11:38 the gore® excluder® endoprosthesis trunk appears to be deployed.The ipsilateral limb on the patient¿s right side appears to be constrained.O at 11:45 there appears to be an olive that appears to be attached to the deployment catheter.O at 11:48 the ipsilateral leg appears to be deployed on the patient¿s right side.O at 11:54 there appears to be a partially deployed device near the left femoral access.(left external iliac artery at the level of the left femoral head.) cannot confirm if this device is being pulled back/removed with the still image provided.O at 12:11 there appears to be a deployed contra lateral leg on the left side of the patient, by the radiopaque markers.O ballooning of implanted devices at 12:11, 12:12, and 12:14.O 12:15:06 there appears to be a probable deployment catheter, a pigtail catheter and 2 sheaths present on the image.O 12:15:39 the deployment catheter appears to be pulled out through access on the right side of the patient and the sheath appears to be pulled back.There also appears to be a radiopaque density present, in the ipsilateral limb on the right side, that did not appear on the image at 12:15:06.O 12:16:19 on the final angiogram run provided for evaluation, the radiopaque density remains in the implanted device(s) on the patient¿s right side.There appears to be a density of unknown origin at the level of the proximal device markers of the device trunk.O probable broken delivery catheter and separated olive proximally.O there appears to be flow throughout the implanted devices.¿ post-implantation cta dated (b)(6) 2019 appears to show: o images appear to show occlusion of the right internal iliac artery.There appears to be calcium within the riia.O flow in the left internal iliac artery appears to be restored on this time-point.O there appears to be a gap, of approximately 4 cm, between the distal end of the contralateral limb in the lci to the proximal end of the stent in the distal lci and the left external iliac artery.O there appears to be lack of stent apposition in the distal lci.O there appears to be a density of unknown origin in the distal lci.Possible separated olive.¿ abdomen xray dated (b)(6) 2019 appears to show: o a density of unknown origin appears to be on the patient¿s left side at the level of the proximal stent in the distal lci and left external iliac artery.¿ abdomen xray dated (b)(6) 2020 appears to show: o the density of unknown origin appears to be on the patient¿s left side at the level of the proximal stent in the distal lci and left external iliac artery.¿ abdomen xray¿s dated (b)(6) 2021 appears to show: o the density of unknown origin appears to remain on the patient¿s left side at the same location as the abdomen x-ray¿s on (b)(6) 2020 and (b)(6) 2019.

Manufacturer Narrative

G1: corrected manufacturing name and address.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13042099
• MDR Text Key: 286512561
• Report Number: 3007284313-2021-01712
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618613
• UDI-Public: 00733132618613
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2021
• Device Model Number: PLC121000
• Device Catalogue Number: PLC121000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 01/06/2022; 02/24/2022; 06/13/2022
• Supplement Dates FDA Received: 02/07/2022; 03/02/2022; 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2018
• 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): Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male