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

Catalog Number JHJR081002J

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

(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 april.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 5 cm 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 5 cm 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 (10 mm x 10 cm) 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: 7588431
• MDR Text Key: 110676205
• Report Number: 2017233-2018-00322
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2020
• Device Catalogue Number: JHJR081002J
• Device Lot Number: 17480792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2017
• 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