MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number VBH111002W

Device Problems Entrapment of Device (1212); Separation Failure (2547); Activation Failure (3270)

Patient Problems Occlusion (1984); Device Embedded In Tissue or Plaque (3165)

Event Date 11/21/2018

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing records verified that the lot met all pre-release specifications.The engineering evaluation and the imaging evaluation are still in progress.

Event Description

It was reported to gore that during an ever treatment, a 11mm x 10cm gore® viabahn® endoprosthesis was to be implanted in the iliac artery as an extension.After being advanced to the target lesion, resistance was reportedly felt.The deployment line was broken when extra deployment force was used.The endo was not deployed.The physician inserted a guide wire and a balloon from the brachial artery to try removing the viabahn device after ballooning, but that did not work.The physician then cut down the access site of the femoral artery in attempt to find the broken end of deployment line, but was unsuccessful.Therefore, the physician had to cut the catheter and the catheter was retracted from the patient's body.The partially expanded endoprosthesis was left inside the patient's body.Then the physician performed a femoral-femoral bypass surgery to re-establish blood flow.

Manufacturer Narrative

Imaging evaluation results: the device was available for analysis.The evaluation results stated that the delivery catheter was returned.The dual lumen catheter shaft was cut in two places, one cut was approximately 20cm from the hub, and the second was approximately 87cm from the hub.These two cuts separated the catheter into two pieces and the transition, distal shaft, deployment line and knob, distal tip, and endoprosthesis were not returned.Based on the device examination performed, no manufacturing anomalies were identified.Based on the device examination performed, no manufacturing anomalies were identified.Contraindications: the gore® viabahn® endoprosthesis with heparin bioactive surface is contraindicated for non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• 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: vickie lang ; 9285263030
• MDR Report Key: 8131743
• MDR Text Key: 129296416
• Report Number: 2017233-2018-00737
• 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,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2020
• Device Catalogue Number: VBH111002W
• Device Lot Number: 17787236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2017
• 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: 85 YR
• Patient Weight: 55