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

Catalog Number JHH101502J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified the lot met all pre-release specifications.

Event Description

The following was reported to gore: on (b)(6) 2017, a patient presented with a stenosis of the left inferior vena cava (ivc) due to cancer infiltration.Bare metal stents were implanted, however, the stents were reportedly not expanded enough.On (b)(6) 2017, it was elected to additionally implant a gore® viabahn® endoprosthesis inside the bare metal stents to repair the stenosis.The jugular vein approach was used, and the delivery catheter was delivered to the left iliac vein.The endoprosthesis was deployed from the left iliac vein to the left inferior vena cava with no reported issues.Following deployment, the delivery catheter was attempted to be withdrawn but it seemed the deployment line was stuck on the bare metal stents implanted previously.Therefore, the deployment line was cut off from the deployment knob outside the patient, and the delivery catheter was able to be withdrawn.A metallic cannula for transjugular intrahepatic portosystemic shunt (tips) was utilized to advance over the remaining deployment line in the vein, and the physician planned to try to cut the deployment line at the stuck portion.At that time, it was reported that the previously adhered deployment line became free before the line was cut, and the entire deployment line was able to be withdrawn from the patient.The patient tolerated the procedure.

• 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: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7081339
• MDR Text Key: 94553008
• Report Number: 2017233-2017-00631
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2019
• Device Catalogue Number: JHH101502J
• Device Lot Number: 15957230
• 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: 10/18/2016
• 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: 81 YR