MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number VBH131002W

Device Problems Obstruction of Flow (2423); Difficult or Delayed Activation (2577); Deformation Due to Compressive Stress (2889)

Patient Problems Failure of Implant (1924); Ischemia (1942); Obstruction/Occlusion (2422)

Event Date 07/29/2022

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

The patient was diagnosed with abdominal aortic dissection under renal artery to common iliac artery.According to ct measurement, the maximum diameter of the abdominal aorta under the bilateral renal arteries was 14.7mm.On (b)(6) 2022, the patient was implanted with two 13mm x 10cm gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) to treat abdominal aortic dissection using kissing technique, without using an abdominal graft stent.The two viabahn devices were advanced to target lesion under angiography.When the physician intended to deploy two viabahn devices at the same time, the right viabahn device was successfully expanded firstly in abdominal aorta to right iliac artery.It appeared that the space in abdominal aortic lumen was insufficient for deployment of left viabahn device.The position of left viabahn device was adjusted during the procedure.It was found that the left viabahn device couldn¿t be completely expanded by pulling out the deployment knob.Then the left viabhan device was fully expanded with the support of a sheath.The final angiography showed that the left viabahn device was compressed and occluded.The blood flow was limited.After performing balloon dilation, the blood flow was slightly improved.The patient had transient ischemic symptoms.On (b)(6) evening, the viabahn device was removed, the blood flow of the lower limb artery was restored, and the patient was in stable condition.On unknown date ((b)(6), under confirmation), the patient expired with unknown reason.

Manufacturer Narrative

During an upgrade to the system, the imdrf codes were inadvertently removed from the original medwatch.

Manufacturer Narrative

A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.The reported primary device failure mode concerning partial deployment and partial device expansion could not be independently confirmed, and the root cause of the deployment difficulty could not be established with the available information, including review of clinical items received.The reported compression of the viabahn® device could not be independently confirmed during imaging evaluation of the items received.However, it was reported two 13 mm diameter viabahn® devices were intended for use in the kissing stent configuration for treatment of an abdominal aortic dissection below the renal arteries.Review of pre-implantation vessel measurements showed vessel lumen flow diameters proximal to and within the lesion ranged from 13.6 to 5.8 mm, respectively.Moreover, the reported event details indicated the space in the abdominal aortic lumen was observed to be insufficient to accommodate deployment of the left viabahn® device.The ifu specifies careful selection of appropriately sized endoprostheses with attention to precise native vessel measurements.Therefore, the reported device compression is consistent with reasonably foreseeable misuse in the selection of an inappropriate diameter for the patient (diameter too big) resulting in stent/vessel occlusion.The gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use (ifu), for the appropriate region and time-period, was reviewed with respect to the complaint detail and there are applicable statements.¿w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn endoprosthesis in applications other than the endovascular grafting of superficial femoral or iliac arteries.¿ the ifu also states: ¿special care should be taken to ensure that the appropriate size endoprosthesis, compatible sheath and guidewire are selected prior to introduction.Native vessel dimensions must be accurately measured, not estimated.¿.

Event Description

It was reported that the patient was diagnosed with abdominal aortic dissection under the renal artery to the common iliac artery.It was reported that according to ct measurements, the maximum diameter of the abdominal aorta under the bilateral renal arteries was 14.7mm.It was reported that on (b)(6), 2022, the patient was implanted with two 13mm x 10cm viabahn® device to treat abdominal aortic dissection using kissing stent graft technique, without using an abdominal graft stent.It was reported that the two viabahn devices were advanced to the target lesion under angiography, and when the physician intended to deploy the two viabahn® devices at the same time, the right viabahn® device successfully expanded in abdominal aorta to right iliac artery, however, it appeared that the space in abdominal aortic lumen was insufficient for deployment of the left viabahn® device.Reportedly, the position of the left viabahn® device was adjusted during the procedure, and it was found that the left viabahn® device couldn¿t be completely expanded by pulling the deployment knob.It was reported that the left viabahn® device was fully expanded with the support of a sheath, and the final imaging showed that the left viabahn® device was compressed and occluded with limited blood flow.Reportedly, after performing balloon dilation of the viabahn® device, the blood flow was slightly improved.It was reported that the patient had transient ischemic symptoms, and on the evening of (b)(6), the viabahn® device was removed, and the blood flow of the lower limb artery was restored, and the patient was in stable condition.It was reported that the patient was discharged on (b)(6) and expired with unknown reason on unknown date.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15301358
• MDR Text Key: 298705296
• Report Number: 2017233-2022-03270
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VBH131002W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male