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

Catalog Number PAC101002

Device Problems Break (1069); Kinked (1339); Activation, Positioning or Separation Problem (2906)

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

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.(b)(4).The device was discarded, so no engineering investigation could be performed.Without additional information it is impossible to further investigate this event.(b)(6).

Event Description

The patient presented with an aneurysm in the internal iliac artery which was intended to be treated with a gore® viabahn® endoprosthesis.Patient¿s vessel access was gained through the left axillary artery where an 11fr introducer sheath and a lunderquist guidewire were used.After placement of the introducer sheath and advancement of the guidewire, the patient¿s vessel seems to be kinked.It was stated that when the gore® viabahn® endoprosthesis was inserted and advanced through the introducer sheath some resistance was experienced.It was stated that when device deployment was initiated and the endoprosthesis partially deployed, the deployment line broke.Further device deployment was not possible and the decision was made to remove the device together with the guidewire through the introducer sheath.The procedure was completed implanting another gore® viabahn® endoprosthesis.The patient is doing well after 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: 6075170
• MDR Text Key: 59361235
• Report Number: 2017233-2016-00839
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: PAC101002
• Device Lot Number: 15019692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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: 11FR INTRODUCER SHEATH, LUNDERQUIST GUIDEWIRE.
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 70