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

Catalog Number BXA052902E

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Death (1802); Thrombosis/Thrombus (4440)

Event Date 08/24/2020

Event Type  Death  

Manufacturer Narrative

The device remains implanted and therefore a further investigation cannot 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

It was reported to gore that patient underwent endovascular treatment for a chronic mesenteric ischemia in the superior mesenteric artery (sma) with a gore® viabahn® vbx balloon expandable endoprosthesis (vbx-device).It was stated that the patient was a former smoker who quitted 25 years before the intervention.A previous cervix cancer was treated with curable intent and no signs of relapse were found on follow-up during biochemical and radiological analyses.The patient suffered also from autoimmune hepatitis and ulcerative colitis.Elective admission for stenosis of the proximal sma resulted in post prandial abdominal pain and subsequent weight loss.It was reported that on (b)(6) 2020 a vbx-device was implanted at ryhov county hospital with no perioperative complications.The patient was administered continuously with asa 75 mg and atorvastatin 40 mg daily.On (b)(6) 2020 a ct scan showed patent stent graft and patent sma.It was stated that on (b)(6) 2020 at 5 am sudden onset of epigastric pain.A ct scan revealed in-stent occlusion of sma.The patient was transported to ryhov county hospital and was treated with an angiojet pharmacomechanical thrombectomy device.In addition, relining of the occluded segment took place which resulted in loss of patency in some sma branches.The immediately following open surgery revealed profoundly ischaemic small bowel that is deemed nonviable and thus removed in a damage control procedure.Reportedly, the patient developed multi organ dysfunction post-operatively and died at noon (b)(6) 2020.

Manufacturer Narrative

H6: result code: 213 - a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.H3: other; there was no device returned; therefore, no physical evaluation of the device could be performed.Imaging evaluation: two time points available for evaluation: pre-implantation cta dated on (b)(6) 2020 and post-implantation cta dated on (b)(6) 2020.No images available during the implantation procedure.(intra-operative angiogram) pre-implantation imaging appears to show: an occluded celiac ostium the proximal sma appears to be stenotic.By outer curve length, ~8mm in the proximal sma has diameters < 3mm (~2.1mm -2.9mm) post-implantation imaging appears to show: a stent in the sma.The stent by outer curve length, appears to be 2.5cm.Contrast flow can be visualized in ~6mm of the proximal stent in the sma.There appears to be some thrombus within the proximal 6mm of implanted device with a possible partial obstruction of flow.The next 23mm of vessel in stent and distal to the stent appears to be occluded.Diameters within the implanted stent appear to range from ~4.5mm ¿ 6.2mm.Engineering evaluation: the referenced complaint did not have a returned device.The following evaluation is based on information obtained from the event description, communication summary, and imaging evaluation.The referenced complaint was for device occlusion.The design of the vbx device is intended to provide a patent lumen, from the ring and film specifications to the heparin coating.The heparin activity tested in process was confirmed to meet the final device specification.The device history file was reviewed, and no anomalies were identified.Machine history files were reviewed, and no non-routine maintenance was identified.Based on the device evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• 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: 11026823
• MDR Text Key: 222010619
• Report Number: 2017233-2020-01535
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2022
• Device Catalogue Number: BXA052902E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 82 YR