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

Catalog Number VBJR081502A

Device Problems Leak/Splash (1354); Device Dislodged or Dislocated (2923)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/07/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, the patient was treated for a thoracoabdominal aortic aneurysm (taaa).Three gore® viabahn® endoprosthesis were used to chimney the celiac artery and superior mesenteric artery (sma).One gore® viabahn® endoprosthesis was placed in the celiac artery and two gore® viabahn® endoprostheses were placed in the sma.On (b)(6) 2015, a type iii endoleak was noted on follow-up cta involving the devices placed in the sma.The gore® viabahn® endoprostheses had dislodged from the sma.On (b)(6) 2015, another gore® viabahn® endoprosthesis was placed in the sma to treat the type iii endoleak.

Manufacturer Narrative

Review of the manufacturing paperwork has been conducted.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Images were returned and evaluated.Select jpeg images were submitted for review.The images provided do not allow for an evaluation in relationship to this event.The following additional lot number was involved in this event: lot #13778345 - mfr report #2017233-2015-00462.

Manufacturer Narrative

Corrected data: date of event - (b)(6) 2015.

• 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 86001
• Manufacturer Contact: roger smith ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4947441
• MDR Text Key: 6635902
• Report Number: 2017233-2015-00463
• 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: Other,Study,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2015

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: 04/01/2018
• Device Catalogue Number: VBJR081502A
• Device Lot Number: 13856030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2015
• 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: 68 YR
• Patient Weight: 48