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

Catalog Number VBH101502W

Device Problems Component Falling (1105); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

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 early (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.The deployment line of the 10mm x 10cm gore viabahn® endoprosthesis which was deployed in the right common iliac artery failed to release from the device and partially remained inside 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 (vbh101502w/14401244) in the right common iliac artery to pin the deployment line segment to the vessel wall.During device deployment, the deployment line of this device reportedly got stuck again when there still had 2-3cm of endoprosthesis not fully expanded and the deployment reportedly could not continue.The physician performed the same actions as that for the previous device, retracting the delivery system carefully to force the device in full expansion.Upon full deployment and while removing the catheter, the deployment line did not release from the device.The physician cut the deployment line to remove the catheter and a segment of the deployment line again remains inside the patient.A type-b ultrasonic inspection 2 days after procedure indicated the deployment line being left inside the vessel.By (b)(6) 2016, it was stated the patient was still stay in the hospital without any complications and no observed patency loss.A post-discharge computed tomography angiography (cta) as follow-up is planned.

• 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: 5740583
• MDR Text Key: 48761457
• Report Number: 2017233-2016-00596
• 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: 08/11/2018
• Device Catalogue Number: VBH101502W
• Device Lot Number: 14401244
• 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: 08/12/2015
• 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