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

Catalog Number PAHR080502E

Device Problems Break (1069); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The patient was presented with an abdominal artery aneurysm which was intended to be treated with a gore® viabahn® endoprosthesis in combination with an endurant stent graft from medtronic in a chimney procedure.It was reported to gore that the endurant stent graft and the extension component were inserted and advanced to the target lesion through femoral access and that medical device deployment was performed successfully.Following implantation of the endurant stent graft and the extension component the gore® viabahn® endoprosthesis was inserted through an 8fr introducer sheath and advanced to the target lesion over a 0.035 guidewire where a brachial access was used.It was reported to gore that when medical device deployment was initiated within one renal artery, some unusual resistances was experienced.As further force was required for the deployment process of the gore® viabahn® endoprosthesis the physician decided to remove the device through the introducer sheath.A visual inspection of the removed gore® viabahn® endoprosthesis indicated that the endoprosthesis was partially deployed (flowering) and that the device catheter shaft was broken.The physician confirmed that no broken component parts remained in the patient¿s vessel.The procedure was completed implanting another gore® viabahn® endoprosthesis.The patient is doing well following the procedure.

• 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: 6731074
• MDR Text Key: 80888142
• Report Number: 2017233-2017-00357
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2019
• Device Catalogue Number: PAHR080502E
• Device Lot Number: 15012933
• 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: 01/08/2016
• 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
• Patient Age: 87 YR
• Patient Weight: 89