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

Catalog Number VBH131002W

Device Problem Separation Failure (2547)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.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 following was reported to gore: on (b)(6) 2021, a patient was to be implanted with a 13mm x 10cm gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) to treat right iliac artery occlusion.The patient's right common iliac artery was dissection and severe stenosis.A 6mm balloon was used to perform pre-dilatation.The viabahn device was advanced to target lesion, the proximal end of device was aligned with the opening of the right common iliac artery, the distal end of device was located in the proximal segment of the right external iliac artery.The deployment line was pulled and viabahn device was fully expanded, but the deployment line cannot be separated with device.Several times were tried to remove deployment line but failed, the distal end of viabahn device was twisted.Physician cut the deployment line and removed delivery system, placed another 10mm x 8cm ev3 stent near the proximal end to viabahn device at external iliac artery, used a 9mm balloon to perform post-dilatation.Deployment line fragments remain in patient.Angiography showed that the abdominal aorta and bilateral iliac arteries were patent, and the distal end of the viabahn was slightly distorted.Patient tolerated the procedure.

Manufacturer Narrative

G4 ¿ updated combination product? yes; h3 ¿ updated was the device evaluated by the manufacturer? yes; h10 ¿ evaluation summary: imaging evaluation summary: the images received are non-dicom.As they are non-dicom the patient info/scan dates are not available.Unable to make any statement regarding a deployment line using any radiographic images due to the lack of the line¿s opacity when imaged.Engineering evaluation summary: the manufacturing records were reviewed, and the device lot met all pre-release specifications.Evaluation of the returned product indicates no conclusions can be drawn related to the reported deployment difficulty.The delivery catheter was returned, but the deployment line, deployment knob, and endoprosthesis were not returned.Distal shaft: appears unremarkable.Dual lumen: appears unremarkable.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Manufacturer Narrative

H6 - update investigation conclusion code with 4315, remove 67.Cause of the reported event cannot be established based on evaluation of the returned delivery catheter and the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

• 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: qiong wang ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12357773
• MDR Text Key: 267834849
• Report Number: 2017233-2021-02301
• 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: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2023
• Device Catalogue Number: VBH131002W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 55 KG