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

Device Problems Inflation Problem (1310); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Activation Failure (3270); Premature Separation (4045)

Patient Problems Unspecified Vascular Problem (4441); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

Patient information: the patient information was requested , but it was not disclosed to gore.The serial number of the device was requested, but could not be obtained.Therefore the manufacturing records of the device could not be reviewed.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

The patient presented with an iliac aneurysm which was treated with a gore® excluder® iliac branch endoprosthesis (ceb).It was planned to implant two gore® viabahn® vbx balloon expandable endoprostheses (vbx devices: vbxl085902e and vbx117902e) in the right internal iliac artery as an extention of the ceb.Access was gained from the left brachial artery with an 8fr flexor® ansel guiding sheath (cook medical).Reportedly, the physician was aware that this sheath might be tight when using the planned vbx devices, but he did not have an alternative 8fr sheath and he would like to avoid going up to 10fr.Vbx device vbxl085902e was placed in the right internal iliac artery as intended with no reported issues.After this the physician wanted to extend the vbx device distally into the right internal iliac artery with vbx device vbx117902e.The physician reported that he felt resistance during advancement of vbx device vbx117902e on the way down and that he could not push the vbx device all the way down to the internal iliac artery.Therefore, he withdrew the vbx device and replaced the 8fr sheath with a 10fr sheath (cook medical).Then he advanced the same vbx device and placed it over the lesion in the internal iliac artery without feeling resistance.When deploying the vbx device the balloon would not inflate.The physician used a manometer, but still he could not fill the balloon.Then the physician withdrew the vbx device again from the patient, but when doing this, he saw that the undeployed stent was still in the internal iliac artery.Then he used an armada¿ percutaneous transluminal angioplasty catheter (abbott) to retract the stent to the brachial access and removed the stent from the patient by surgical cut down to the brachial artery.At this stage the physician decided to terminate the intervention.It was reported, that the aneurysm was not excluded distally at the end of the procedure.It is planned to perform a reintervention to exclude the aneurysm distally.Reportedly, the patient is doing well.

Manufacturer Narrative

H6-code 4119: the serial number of the device was requested, but it could not be provided.H6-code 4111: dicom imaging series have been requested from the physician for evaluation but no images were available.H6-code 213: the serial number remains unknown, therefore the device history records could not be reviewed.The device was returned to gore for evaluation.The product evaluation summary states the following: the returned device was confirmed as a gore® viabahn® vbx balloon expandable endoprosthesis device (11 mm x 79 mm, with 135 cm delivery system).It was returned as two separate components: a).The delivery catheter and b).The endoprosthesis, attached to a pta catheter.The returned vbx delivery catheter was able to be inflated to the nominal inflation pressure of 10 atm, and subsequently deflated.The endoprosthesis appeared to be compressed axially with observed stacking of the stent rings.Several stent rings were also observed to have bent or flared apices.Catheter damage was observed at 44.5 cm - 45.5 cm, as measured from the strain relief shrink sleeve of the hub assembly.The cause of the device damage could not be confirmed.

Manufacturer Narrative

It the instructions for use the following is stated: do not withdraw the gore® viabahn® vbx balloon expandable endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore® viabahn® vbx balloon expandable endoprosthesis back into the sheath can cause dislocation and/or damage to the endoprosthesis, premature deployment, deployment failure, and/or catheter separation.If removal prior to deployment is necessary, withdraw the gore® viabahn® vbx balloon expandable endoprosthesis to a position close to but not into the introducer sheath.Both the gore® viabahn® vbx balloon expandable endoprosthesis and introducer sheath can then be removed in tandem.After removal, do not reuse the gore® viabahn® vbx balloon expandable endoprosthesis or introducer sheath.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11421100
• MDR Text Key: 243812647
• Report Number: 2017233-2021-01736
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: DA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization