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

Model Number VBJR081502A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 01/10/2017

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: review of the manufacturing records could not be performed as no lot number information was provided.The device was not returned.Consequently, a direct product analysis was not possible.All information has been placed on file for use in tracking and trending.

Event Description

The doctor reported to gore the following: a gore® viabahn® endoprosthesis was previously placed (unknown date) in the popliteal artery to exclude an aneurysm.Today ((b)(6) 2017) the gore® viabahn® endoprosthesis appeared to have migrated proximally so a re-intervention occurred placing another gore® viabahn® endoprosthesis.

Manufacturer Narrative

Additional manufacturer narrative: method code - images received via (email)do not allow for evaluation in relationship to this event.(b)(4).

Manufacturer Narrative

Additional manufacturer narrative: review of the manufacturing records verified that the lot met release requirements.

Manufacturer Narrative

Catalogue number - vbjr081502a, model number - na.

Event Description

Gore was notified of the following by the doctor: on (b)(6) 2016, a gore® viabahn® endoprosthesis was placed in the popliteal artery to exclude an aneurysm with a 4cm distal landing zone.The patient (long distance runner/biker training for an iron man competition) reported that around christmas felt slightly more pain but did not seek medical help at that time.On (b)(6) 2017, during a routine follow up arterial duplex, stent migration was discovered.According to the doctor, the stent appeared to have migrated/shortened proximally with the distal end about 1cm into the aneurysm, so total migration distance was approx.5 cm.On (b)(6) 2017 a second gore® viabahn® endoprosthesis was implanted successfully excluding the aneurysm.

• 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: craig bearchell ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6294604
• MDR Text Key: 66319006
• Report Number: 2017233-2017-00059
• 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,Followup,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2018
• Device Model Number: VBJR081502A
• Device Catalogue Number: VBJR081502A
• Device Lot Number: 14120797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/09/2017; 03/21/2017; 03/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2015
• 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: 48 YR
• Patient Weight: 78