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

Catalog Number VBC081502

Device Problems Break (1069); Sticking (1597); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2017, a gore® viabahn® endoprosthesis (vbc081502/15424301) was to be implanted in the hepatic portal vein in tips procedure.It was reported that a resistance was felt after initiating deployment, the deployment line was stuck in the first layer of zipper and the deployment could not be continued.The endoprosthesis was still constrained.The viabahn device was retracted slowly out of the patient.After retraction, the device was observed being broken at the transition bond of catheter, the distal shaft being constrained with endoprosthesis was detached but still connected by the deployment line.The procedure was completed by using a new 8 mm x 10 cm viabahn® device.

• 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: 6394173
• MDR Text Key: 69875031
• Report Number: 2017233-2017-00117
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: VBC081502
• Device Lot Number: 15424301
• 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: 06/01/2016
• 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: 62 YR
• Patient Weight: 60