MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® VIABAHN® ENDOPROSTHESIS; NIP

Catalog Number JHJR080502J

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Stenosis (2263); Obstruction/Occlusion (2422)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Udi: (b)(4).

Event Description

On (b)(6) 2018, the patient underwent an endovascular repair for a chronic total occlusion of the right external iliac artery and the right common femoral artery using two gore® viabahn® endoprosthesis (jhjr081002j/17480792 and jhjr080502j/17480757).Moreover, the patient underwent an endovascular repair for an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses during the same procedure.On (b)(6) 2018 the patient underwent an endovascular repair for thoracic aortic aneurysm using two conformable gore® tag® thoracic endoprosthesis.A 24fr gore® dryseal flex sheath (dsf2433/17759897 or dsf2433/17759674) was inserted from the right common femoral artery.However, the sheath could not be advanced since the tip of the sheath was caught by the distal edge of the gore® viabahn® placed in (b)(6).Balloon angioplasty was performed and another 22fr gore® dryseal flex sheath (dsf2233/17770000) was used, but the 22fr sheath also could not be advanced.Therefore, the physician decided to cut the 24fr gore® dryseal flex sheath.The working length of the sheath became 5cm after the physician cut the sheath.The first conformable gore® tag® thoracic endoprosthesis (tgu343420j/179511304) was inserted into the 5cm sheath and the stent graft was placed just below the left subclavian artery.There was no resistance noted when the delivery catheter was inserted through the gore® viabahn®.Then the second conformable gore® tag® thoracic endoprosthesis (tgu454520j/17980505) was inserted and angiography was performed.It revealed the two gore® viabahn® endoprosthesis were moved proximally and positioned around superior mesenteric artery.It was thought the two gore® viabahn® endoprostheses were pushed up by the delivery catheter of conformable gore® tag® thoracic endoprosthesis (tgu454520j/17980505) although no resistance was encountered during the insertion of the delivery catheter.The second conformable gore® tag® thoracic endoprosthesis (tgu454520j/17980505) was removed from the patient.Then a balloon was expanded in the two gore® viabahn® endoprostheses and those were removed with the 5cm sheath outside of the patient.No access vessel rupture was observed.The second conformable gore® tag® thoracic endoprosthesis (tgu454520j/17980505) was again inserted and placed from zone 0 to zone 3 after another 24fr gore® dryseal flex sheath was inserted.Two gore® viabahn® endoprostheses (10mm x 10cm) were placed in the right external iliac artery and the right common femoral artery.The left subclavian artery was embolized and the procedure was completed.The patient tolerated the procedure.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• 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: douglas rhodes ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7588472
• MDR Text Key: 110702818
• Report Number: 2017233-2018-00323
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2020
• Device Catalogue Number: JHJR080502J
• Device Lot Number: 17480757
• 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: 08/31/2017
• 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: 81 YR