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

Catalog Number VBH101002W

Device Problems Sticking (1597); Difficult to Advance (2920)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The review of the manufacturing records verified that this lot met all pre-release specifications.Based on intra-operative angiography images, the investigation stated that the images received were without patient identifier or date of acquisition in image.The images provided did not allow for evaluation in relationship to this event.

Event Description

On (b)(6) 2016, two 10mm x 10cm gore viabahn® endoprostheses were to be implanted for treatment of occlusion of both common iliac arteries by kissing technique.Both devices were accessed through the 11f cook sheaths and advanced via supercore stiff guide wires.There was no resistance when advancing the devices to the target lesion and initiating deployment.The first 10mm x 10cm device was accessed from the left common femoral artery and successfully deployed in the left common iliac artery.During deployment of the second 10mm x 10cm device ((b)(4)) in the right common iliac artery, it was reported the deployment line got stuck when approximately 2-3cm endoprosthesis not been expanded and the deployment could not continue.The physician carefully retracted the delivery system and pulled the olive tip through the remaining constrained device, thereby completing deployment.However, the deployment line could not be released from the device.The physician cut the deployment line to remove the catheter and approximately 20cm of deployment line remained in the patient.To avoid any thrombosis caused by the deployment line remaining inside, the physician decided to implant a 10mm x 15cm gore viabahn® endoprosthesis ((b)(4)) in the right common iliac artery to pin the deployment line segment to the vessel wall.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: helen huang ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5740655
• MDR Text Key: 48770776
• Report Number: 2017233-2016-00595
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2019
• Device Catalogue Number: VBH101002W
• Device Lot Number: 14957960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2016
• 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 Age: 64 YR
• Patient Weight: 75