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

Catalog Number BXA087902E

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

Patient Problems Death (1802); Ischemia (1942); Thrombosis (2100)

Event Date 08/26/2020

Event Type  Death  

Manufacturer Narrative

A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.Dicom series have been requested and provided.They are currently being evaluated.The device remains implanted.Therefore an engineering evaluation could not be performed.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

On (b)(6) 2020, the patient underwent a branched endovascular aortic repair (bevar) to treat a thoraco-abdominal aneurysm type v with customized main aortic endoprosthesis (cook).Four gore® viabahn® vbx balloon expandable endoprostheses (viabahn vbx device) were implanted to extend the branches into the left renal artery, the right renal artery, the superior mesenteric artery (sma) and the celiac artery (ca).The viabahn vbx devices in sma and ca were extended with a begraft peripheral plus stent graft (bentley).All viabahn vbx devices were navigated to their intended locations and deployed without issues.At the end of the procedure all viabahn vbx devices were patent.The patient tolerated the procedure.On (b)(6) 2020, the patient was admitted to the hospital because of severe abdominal pain for three days.Reportedly the patient has discontinued the anticoagulation medication because of increasing nausea and vomiting.Blood test marker results for inflammation indicated sever inflammatory processes.An x-ray imaging indicated an ileus of the small intestine.A computed tomography showed that all implanted endoprosthesis were located as intended.It is stated that the patient gradually went into shock, so they decided to have emergency laparotomy.Reportedly there was a very bad smell and no pulse was present at the level of the mesenteric root.The small intestine was ischemic reaching from the suspensory ligament of treitz to the ileocecal valve.The laparotomy was terminated without further action.On (b)(6) 2020, the patient passed away because of advanced stage small intestine ischemia.

Manufacturer Narrative

H6-code 4112: dicom series have been provided for investigation.H6-code 213: the imaging evaluation states the following: three time points submitted for evaluation: pre-implantation cta dated on (b)(6) 2020, post-implantation cta dated on (b)(6) 2020 and post-implantation ct (non-contrast) dated on (b)(6) 2020.Sagittal reconstructed images from on (b)(6) 2020 time point appear to show stents extending into the celiac artery and sma.The celiac artery and sma appear to be patent on this time point.Last time point on (b)(6) 2020 is a non-contrast ct.Flow through the stents cannot be confirmed or unconfirmed without contrast.

• 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: 10770339
• MDR Text Key: 214109164
• Report Number: 2017233-2020-01396
• 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: study
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/25/2022
• Device Catalogue Number: BXA087902E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Disability
• Patient Age: 80 YR
• Patient Weight: 100