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

Catalog Number PAH081502

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 12/02/2014

Event Type  malfunction  

Event Description

The patient presented with a popliteal artery aneurysm which was treated with four gore® viabahn® endoprostheses.The four devices were implanted successfully.It was reported to gore that when the physician took out the balloon from the introducer sheath, a thread came out together with the balloon.It is unknown if the thread was from any of the viabahn devices or not.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Manufacturer Narrative

When medical device was physically returned, the following observations were made: the sample returned to histology consisted of fibers only and no device.The tangled fibers were separated to reveal 4, unequal fragments as follows: a- approximately 58 cm, b- approximately 38 cm, c- approximately 34 cm, d- approximately 21 cm.All 4 fibers were made of similar, monofilament material and had an elongated cross-section.The middle of fiber b was frayed.Fiber c had a piece of fibrous debris wrapped around its middle.The returned fibers do not resemble any manufacturing aids or components used in viabahn products other than the deployment line.The fact that the fibers were of unequal length, not braided together, and presumably located inside the endoprosthesis lumen is inconsistent with any anticipated failure mode.As no other device components were returned with the specimen, it is not possible to determine the exact origin of these fibers or describe the conditions that led to this rare occurrence.Based on the device examination performed, no manufacturing anomalies were identified.This type of occurrence will continue to be trended and appropriate actions taken as they are deemed necessary.Correction: this incident belongs to a product problem/malfunction of the medical device and not to a serious injury as reported previously.

• 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: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4365839
• MDR Text Key: 5234606
• Report Number: 2017233-2014-00677
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: PAH081502
• Device Lot Number: 11909003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2015
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2013
• 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
• Treatment: 12 FR INTRODUCER SHEATH, BALLOONS
• Patient Outcome(s): Other
• Patient Age: 79 YR