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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 07/20/2020

Event Type  Injury  

Manufacturer Narrative

The lot/serial numbers were not available, therefore a review of the manufacturing records for the device was not possible.The udi for the vbx devices is not available since the device lot number is unavailable.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use (ifu) states that adverse events that may occur is device failure.

Event Description

On (b)(6) 2019, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.Reportedly, during the original procedure two gore® viabahn® vbx balloon expandable endoprostheses were used for a chimney technique in the renal arteries (lot/serial number is unknown and not available).It was reported that computed tomography images dated (b)(6) 2020, revealed the patient had a proximal type i endoleak.It is unknown if there is aneurysm sac enlargement (previous ct images are not available for comparison).The cause for the type i endoleak is unknown, but the physician stated "it could be possible gutters that lead to possible migration".On (b)(6) 2020, the physician reintervened and implanted a gore® excluder® aortic extender endoprosthesis proximally and bilaterally extended proximally both viabahn® vbx balloon expandable endoprostheses.The endoleak was resolved at the end of the case.The patient tolerated the procedure.

Manufacturer Narrative

Addition -patient comorbidities: copd, hypertension, and afib.Addition -patient medications: albuterol, amlodipine, apixaban, calcium citrate, vitamin d3, duloxetine, famotidine, fenofibrate micronized, ferrous gluconate, fluticasone, gabapentin, levothyroxine, metoprolol, omeprazole, rosuvastatin, solifenacin, sotalol, umeclidinium, valsartan, and zinc oxide.

Manufacturer Narrative

Addition g5.

Manufacturer Narrative

Correction d1/d2 addition g3/g4 addition cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• 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
• MDR Report Key: 10609359
• MDR Text Key: 209259572
• Report Number: 2017233-2020-01312
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/10/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 09/21/2020; 09/21/2020; 09/21/2020
• Supplement Dates FDA Received: 10/02/2020; 01/13/2021; 03/10/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 93