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

Catalog Number VBH101002W

Device Problems Positioning Failure (1158); Sticking (1597); Physical Resistance (2578)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(4).The review of the manufacturing records verified that this lot met all pre-release specifications.Per the gore® viabahn® endoprosthesis instructions for use (ifu), a warning is given that w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications other than the endovascular grafting of superficial femoral or iliac arteries.Furthermore, w.L.Gore & associates acknowledges that although rare, complications and adverse events such as deployment failure may occur.

Event Description

It was reported to gore that the patient had an abdominal artery dissection extending to both common iliac arteries, but the dimension of the iliac artery in the access site was just 5mm and not able to access an abdominal endoprosthesis, so the physician decided to implant two 10mm * 10cm gore® viabahn® endoprosthesis by kissing technique from the abdominal artery extending into both common iliac arteries.Both two viabahn® devices were accessed from the common iliac artery to the target lesion and initiated deployment at the same time.The viabahn® device extending into the left iliac artery was deployed successfully.However, when the viabahn® device extending into the right iliac artery was expanded about 5cm, a resistance was felt but the deployment still could be continued.Until the last 1cm stent was not deployed, the deployment line was seriously stuck, therefore the physician completed deployment with an extra force.After that, this viabahn® device was reportedly compressed distally about 2cm, and a broken deployment line being connected to this viabahn device was left inside the patient.The physician additionally implanted a 10mm * 5cm viabahn® device in the proximal as extension graft to fix the proximal compression.There had no action to be taken to fix the broken deployment line inside the patient and just a follow-up after the procedure was decided.The procedure was successful and the patient was doing well.

Manufacturer Narrative

(b)(4).An engineering evaluation for the returned device has been performed.The investigation stated that a catheter was returned with a deployment knob still attached.No endoprosthesis was returned.The remainder of the catheter appeared unremarkable.A second deployment knob with deployment line attached was returned.The end of the deployment line appeared normal.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: helen huang ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7107271
• MDR Text Key: 95747357
• Report Number: 2017233-2017-00641
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2019
• Device Catalogue Number: VBH101002W
• Device Lot Number: 16199839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2016
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 49 YR