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

Model Number	BXA082902A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Stroke/CVA (1770); Thrombosis/Thrombus (4440)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2022, a thrombectomy was performed prior to device placement.Treatment was performed due to an aneurysm in the subclavian artery.A 7fr x 45cm terumo sheath was used to advance a 7x29 gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).The vbx device was implanted with good results.The patient did not experience any adverse consequences during this treatment.Later the same day, the patient was brought back into the operating room because the 7x29 vbx device had occluded.Intervention was performed with an 8x29 vbx device that extended from the first device and into the aorta.Completion angiography showed the vbx device was open with good flow at conclusion of procedure.Post-operatively on (b)(6) 2022, the patient experienced a right side, posterior circulation stroke.The patient has multiple areas of stroke, echo negative.The physician reported the patient cannot move his left arm and exhibited confusion.The patient's mental status has somewhat improved, although still experiencing some slurred speech/dysarthria as of on (b)(6) 2022.The physician stated that not initially extending the vbx device into the aorta may have possibly caused the occlusion.Other possible explanation was a small calcification or dissection that was not appreciated on angiography.Imaging showed the vbx device remains fully expanded and no collapse was noted.There were no structural deformities seen in the vbx device.
Additional Manufacturer Narrative
Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Patient weight, age/dob, relevant medical history and medications were requested, but not made available.Results pending completion of engineering evaluation.Ifu for gore® viabahn® vbx balloon expandable endoprosthesis hazards and adverse events state: 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.A possible complication which may occur in conjunction with the use of systemic heparin: hit type ii.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.
Additional Manufacturer Narrative
Device remains implanted; therefore, direct product analysis was not possible.The reported complaint information does not reasonably suggest a potential malfunction has occurred.Additional information obtained from physician indicates the reported failure mode, related to device occlusion, may have been caused by not initially extending the vbx device into the aorta.Other possible explanation was a small calcification or dissection that was not appreciated on angiography.The vbx stent was fully expanded and did not collapse.There were no structural deformities noted in the vbx device.D9: device remains implanted; was not returned.Direct product analysis could not be conducted.
Additional Manufacturer Narrative
Gore® viabahn® vbx balloon expandable endoprosthesis (vbx device), catalog number bxa072902a, device lot/serial number (b)(6); udi number (b)(4).This 7 x 29 vbx device was initially implanted in the patient.A second vbx device (8mm x 29mm) was used to extend the initially implanted device.The vbx devices are same device type and the both were implanted in the same target treatment area.For lot/serial number 24817419, a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.The implanting physician stated that not initially extending the vbx device into the aorta may have possibly caused the occlusion.Other possible explanation was a small calcification or dissection that was not appreciated on angiography.The vbx device was fully expanded and was not collapsed.There were no structural deformities noted.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: 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: 14438443
• Report Number: 2017233-2022-02938
• Device Sequence Number: 17443957
• Product Code: PRL
• UDI-Device Identifier: 00733132637553
• UDI-Public: 00733132637553
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2024
• Device Model Number: BXA082902A
• Device Catalogue Number: BXA082902A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 05/19/2022; 05/19/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 05/20/2022; 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male