MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number VBH081002

Device Problems Unintended Collision (1429); Difficult to Remove (1528); Retraction Problem (1536); Activation Failure (3270)

Patient Problem No Code Available (3191)

Event Date 02/13/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, a gore® viabahn® endoprosthesis with heparin bioactive surface was being deployed in the cephalic arch of a patient to repair the residual stenosis and bleeding after angioplasty.The procedure was performed in an outpatient setting in a dialysis clinic.It was reported to gore that after the gore® viabahn® endoprosthesis with heparin bioactive surface deployed, the proximal portion of the endoprosthesis did not fully expand.It was stated that the catheter was unable to be pulled back through the endoprosthesis to remove it from the patient and was caught on the struts of the stent graft.The patient was transferred to the er of a nearby hospital and a surgical procedure was performed under general anesthesia to remove the catheter.

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The images have not yet been received by gore.

Manufacturer Narrative

After multiple attempts, images have not been provided.This event will be closed with the information provided.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: sandra whicker ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4610822
• MDR Text Key: 5762176
• Report Number: 2017233-2015-00158
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: VBH081002
• Device Lot Number: 10243639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2012
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 89