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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Embolism (1829)

Event Date 02/20/2018

Event Type  Injury  

Manufacturer Narrative

No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.The device was not returned.Therefore, direct product analysis was not possible.Instructions for use for gore® viabahn® endoprosthesis states in the intended use / indications section: the gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference vessel diameters ranging from 4.0 ¿ 7.5 mm.The gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions with reference vessel diameters ranging from 4.0 ¿ 12 mm.Warnings section state: w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore.

Event Description

The following abstract was reviewed: ruptured extracranial carotid artery: endovascular treatment with covered stent graft.Since january 2009, eight patients with extracranial carotid artery rupture received endovascular treatment with covered stent graft.The patient records and radiologic findings were reviewed retrospectively.Technical success and immediate hemostasis were achieved in all cases.Gore® viabahn® endoprostheses were used in four of the eight patients.One patient presented with neck swelling and pain.Ruptured site was in common carotid artery (cca) and cause of injury was listed as spontaneous.Ct findings showed hematoma and pseudo-aneurysm (pa); dsa findings show pa of left distal cca.Angiography after deployment revealed atherosclerotic stenosis in the cervical segment of the internal carotid artery (ica).It was reported the patient experienced postoperative complications.One the second day mri, the patient presented minor stroke in the ipsilateral cerebrum.However, the patient fully recovered from the neurological symptoms during follow-up periods.No intervention was reported.Further information was requested but not made available.

• 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: genevieve begay ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8157830
• MDR Text Key: 130307778
• Report Number: 2017233-2018-00761
• Device Sequence Number: 1
• Product Code: PFV
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 69 YR