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

Catalog Number PAJR051502E

Device Problems Break (1069); Detachment Of Device Component (1104); Sticking (1597)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.(b)(4).The endoprosthesis remains implanted and the delivery system of the medical device was discarded, so no engineering evaluation could be performed.

Event Description

The patient presented with an occlusion of the left superficial femoral artery which was treated with a gore® viabahn® endoprosthesis where access was gained through the patient¿s right groin.The gore® viabahn® endoprosthesis was inserted through a 6fr introducer sheath and advanced over a 0.018 guidewire.The diseased lesion was pre dilated and the endoprosthesis successfully deployed.It was reported to gore that while the device catheter was removed the distal catheter shaft got stuck on the guidewire inside the sheath close to the haemostatic valve.A pair of artery forceps was used to pull the catheter out of the sheath where some force was expended resulted in a detachment of the distal catheter shaft as it was pulled through the haemostatic valve.Entire broken viabahn device parts were able to be retrieved.It was stated that the patient was not harmed during the procedure.

Manufacturer Narrative

A correction was made for initial reporter¿ as (b)(6) is not a physician but rather an other healthcare professional.Additional information will be provided within this report as the device catheter of the gore® viabahn® endoprosthesis was returned to gore for evaluation.Our engineers evaluation showed following: the catheter was returned.No deployment line, knob, or endoprosthesis was returned.The portion of broken distal shaft with distal tip was not returned.The transition appears melted and bonded.There is a fragment of distal shaft material present inside the transition with approximately 20mm of insertion.The distal shaft appears broken at the tip end of the transition, which is also damaged.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• 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 86005
• Manufacturer Contact: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6295562
• MDR Text Key: 66608172
• Report Number: 2017233-2017-00061
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2019
• Device Catalogue Number: PAJR051502E
• Device Lot Number: 15146964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2016
• 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
• Treatment: 6FR INTRODUCER SHEATH, 0.018 GUIDEWIRE.