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

Catalog Number BXA082902E

Device Problems Difficult to Insert (1316); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

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 fenestrated and branched endovascular aneurysm repair (fevar) in a superior mesenteric artery (sma) stent with a gore® viabahn® vbx balloon expandable endoprosthesis (vbx-device).It was stated that a 7fr 70cm long cook flexor sheath with access inner diameter 2.54mm was inserted over a 260cm long stiff cook amplatz guidewire and placed in the sma.It was reported that it was impossible to advance the vbx-device (bxa082902e) with outer diameter 2.40mm through the sheath.The delivery catheter stripped and showed a shape like an accordion.It was stated that the viabahn-device must be removed, as the catheter was seriously damaged.Reportedly, a new vbx-device must be unpacked, the sheath was changed to an 8.5fr oscor steerable sheath and the new prosthesis could be implanted successfully without further problems.There was no report of patient harm.

Manufacturer Narrative

H6 evaluation codes investigation findings 213 refers to the phr-review.A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Engineering investigation: evaluation of the returned device identified a catheter kink at 58.5 cm and catheter damage was observed at 59.5 to 61 cm, as measured from the strain relief shrink sleeve of the hub assembly.Manufacturing records indicated the device lot met all pre-release manufacturing specifications, including 100% final visual inspection of each device.A device profile larger than design specifications could contribute to insertion difficulties; however, device profile is 100% inspected using an image measurement system.In addition, after final assembly a subset of devices are subjected to qc batch testing where the finished device is inserted through a new, appropriately sized introducer sheath, in a laboratory-based test method designed to confirm acceptable device function and endoprosthesis deployment.The reported inability to advance the vbx device through the introducer sheath could not be confirmed and the root cause could not be established.

Manufacturer Narrative

H1 / h2 type of reportable event: instead of malfunction it must be "other".Correction: the medical device was returned to w.L.Gore & associates for investigation.The engineering evaluation revealed that the medical device catheter was kinked, and the initial reported catheter break could not be confirmed.Furthermore, no patient harm was reported.Therefore, the reported incident does not meet the reporting criteria for a serious incident and will be therefore retracted.

• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11358344
• MDR Text Key: 249989138
• Report Number: 2017233-2021-01690
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2023
• Device Catalogue Number: BXA082902E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2020
• 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
• Treatment: FEVAR DEVICE FROM COOK MEDICAL.
• Patient Age: 79 YR
• Patient Sex: Female