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

Catalog Number JHH101502J

Device Problems Difficult or Delayed Positioning (1157); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The review of the manufacturing paperwork verified that the lot met all pre-release specifications.(b)(4).

Event Description

The following was reported to gore: in (b)(6) 2017, this patient underwent endovascular procedure using non-gore device (endurant).A bare metal stent (smart) was also implanted distal to the left leg of the device to prevent occlusion.On an unknown date after the procedure, a distal type i endoleak from the left leg was confirmed.On (b)(6) 2017, reintervention was performed to repair the endoleak using a gore® viabahn® endoprosthesis (10mm x 15cm).The left femoral artery approach was used.A gore® dryseal sheath with hydrophilic coating (12fr) was advanced over an extra stiff guidewire, and the delivery catheter was advanced.Angiography could not show a tortuosity of anatomy as the artery was straighten.The guidewire was exchanged to a radifocus guidewire, however, the condition was not so changed.The deployment knob was then slowly pulled.Resistance was reportedly felt after about two thirds of the endoprosthesis was opened, and it was not opened further.It was suspected that the deployment line was stuck on the proximal end of the smart stent.The physician moved the delivery catheter back and forth, however, it was unable to pull the deployment line further.It was also unable to pull the delivery catheter inside the sheath at that time.During the procedure, the endoprosthesis was totally opened as it was pushed by blood flow.The physician cut the deployment line outside the patient, and the delivery catheter was withdrawn from the patient.An attempt was made to pull the fragment of the deployment line away, however, it was not a success.There was also a pre-existing stenosis in the left external iliac artery, and the physician elected to implant a bare metal stent (smart) in the artery to put the fragment of the line between the stent and the artery and to repair the stenosis.An extra fragment of the line was cut, and the procedure was concluded.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: saori kawai ; 9285263030
• MDR Report Key: 6989666
• MDR Text Key: 91331635
• Report Number: 2017233-2017-00572
• 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: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2018
• Device Catalogue Number: JHH101502J
• Device Lot Number: 14852565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2015
• 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: 82 YR