MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® VIABAHN® ENDOPROSTHESIS; NIP

Catalog Number PAH131002E

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Imaging evaluation: the received angiographic image illustrating two (2) gore® viabahn® endoprostheses.The one (1) gore® viabahn® endoprosthesis appears to have a wire in situ.(b)(4).It was stated to gore that, after the hospital completed their investigations on the medical device, the remaining parts of the gore® viabahn® endoprosthesis will be available for gore for further evaluations.

Event Description

It was reported to gore that two gore® viabahn® endoprostheses were implanted reaching from the left subclavian and jugular vein to the innominate vein in a parallel fashion.Reportedly, the first gore® viabahn® endoprosthesis was inserted through a 12fr introducer sheath and advanced over a 0.035 guidewire.Access was gained through the left femoral vein and the gore® viabahn® endoprosthesis was successfully implanted from left subclavian to the innominate vein.It was stated that following complete deployment the deployment line, the guidewire and the delivery system were intentionally not removed.Prior to the implant a stenosis within the left subclavian vein was predilated in presence of pacemaker electrode cables.The second gore® viabahn® endoprosthesis was inserted likewise through a 12fr introducer sheath and advanced over a 0.035 guidewire through the right femoral vein.In order to align the proximal portions of both gore® viabahn® endoprostheses the delivery system of this second device was slightly retracted.Following successful deployment the deployment line, the guidewire and the delivery system were successfully removed.However, when attempting to remove the deployment line of the first implanted endoprosthesis some resistance was experienced and it was not possible to pull the deployment line any further.It was suspected that the deployment line had been caught up at the second implanted gore® viabahn® endoprosthesis.Therefore, it was decided to cut off the deployment knob portion to gain access to the deployment line through the delivery system.Subsequently, a 6fr guiding catheter was inserted via the guidewire to reach the hub of the proximal portions of the endoprostheses in the left innominate vein and in order to pull the deployment line.However, the deployment line could not be removed.The physician elected to inflate a balloon inside the first endoprosthesis but a further deployment line removal attempt was also unsuccessful.The procedure concluded by cutting off the deployment line and closure of the access side.An echocardiography, which was performed 24 hours after the implant, indicated that the wire followed the blood flow, from the proximal portion of the endoprosthesis, implanted in the left innominate vein to superior vena cava, into the right atrium, tricuspid valve and right ventricle, just before pulmonary valve.The patient is doing well following the procedure and will be monitored.

Manufacturer Narrative

Our engineers have evaluated the returned device.Their investigation showed following: a delivery catheter and a piece of deployment line were returned.The deployment knob and endoprosthesis were not returned.The deployment line was approximately 98 cm.One end appeared broken or cut and had 2 fibers that extended past the deployment line by 10 and 11.5 cm.This side of the deployment line appeared broken or cut.The other end appeared normal.The delivery catheter appeared unremarkable.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• 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: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7044629
• MDR Text Key: 93567452
• Report Number: 2017233-2017-00614
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2019
• Device Catalogue Number: PAH131002E
• Device Lot Number: 15963521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2016
• 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: 69 YR