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

Catalog Number PAC081002

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The review of the (manufacturing, sterilization, packaging, boxing) paperwork verified that this lot met all pre-release specifications.

Event Description

The following was reported to gore: on (b)(6) 2012, the patient underwent treatment of an aneurysm within the popliteal artery with two gore® viabahn® endoprosthesis.On (b)(6) 2012, a migration of the distal endoprosthesis has been detected, resulting in a type ib endoleak.The endoleak was successfully solved with the implantation of another gore® viabahn® endoprosthesis on (b)(6) 2012.The patient tolerated the procedure.

Manufacturer Narrative

Updated event description.

Event Description

The following was reported to gore: on (b)(6) 2012, the patient underwent treatment of an aneurysm within the popliteal artery with two gore biabahn endoprosthesis.On (b)(6) 2012, a proximal migration of the distal endoprosthesis was detected, resulting in a type ib endoleak.The endoleak was successfully solved with the implantation of another gore biabahn endoprosthesis on (b)(6) 2012.The patient tolerated the procedure.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).

• 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: joerg kersten ; 9285263030
• MDR Report Key: 5938782
• MDR Text Key: 54277972
• Report Number: 2017233-2016-00743
• 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: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/15/2016

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: 03/31/2015
• Device Catalogue Number: PAC081002
• Device Lot Number: 10204872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/17/2016; 10/18/2016; 12/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 77