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

Catalog Number JHH110502J

Device Problem Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/06/2017

Event Type  Injury  

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: on (b)(6) 2017, this patient underwent endovascular procedure with non-gore device (najuta thoracic stent graft system) and a gore® viabahn® endoprosthesis using chimney technique.The delivery catheter of the gore® viabahn® endoprosthesis was inserted from the left brachial artery, and the endoprosthesis was deployed from inside of the najuta to the left subclavian artery.Reportedly, the physician withdrew the delivery catheter during the deployment of endoprosthesis as a position of the endoprosthesis was moved over a little.After the endoprosthesis was deployed, it was noticed that the delivery catheter could not be withdrawn.It was reported that the deployment line could not be removed from the delivery catheter.The physician elected to cut the deployment line outside the patient, and the delivery catheter was able to be withdrawn.A catheter was inserted over the deployment line remained in the artery and the proximal portion of the endoprosthesis was pushed by the catheter.However, the deployment line could not be withdrawn.It was elected to incise the axillary artery, and the deployment line was cut as short as possible.The proximal portion of the deployment line was left in the artery as it was.After that, 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: 7078246
• MDR Text Key: 93558337
• Report Number: 2017233-2017-00630
• 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,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2018
• Device Catalogue Number: JHH110502J
• Device Lot Number: 14852772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2015
• 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 Outcome(s): Other