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

Catalog Number VBC080502

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Rupture (2208)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: gore® dryseal® sheath.The therapy date was (b)(6) 2017.(b)(4).The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Event Description

On (b)(6) 2017, the patient was treated an aortic dissection with a 34mm x 20cm gore® tag® thoracic endoprosthesis.The tag® device was inserted via a 22f sheath and well deployed.After post-implantation angiography and during retraction of the sheath, the blood pressure(systolic pressure) dropped down to 40mmhg, a rupture of the right iliac artery was confirmed by a contrast leak under angiography.Therefore a 8mm x 5cm gore® viabahn® endoprosthesis(vbc080502/14155527) was immediately implanted to fix the rupture.However after deployment of viabahn® device, the patient's blood pressure still continue dropping down.The physician performed an emergent surgical conversion, used a vascular graft to replace the ruptured iliac artery and removed the deployed viabahn® device.According to the physician, the condition of vessel was not good and with calcification and ulcer, which might cause the rupture when inserting the sheath and the rupture was observed until retraction of the sheath.The patient prolonged the time staying in hospital after open surgery and was stable by the date of reporting.

Manufacturer Narrative

The device was returned to w.L.Gore & associates for investigation.Submitted unfixed was one gore® viabahn® endoprosthesis.The lumen of the device was widely patent.The luminal and abluminal device surfaces were grossly devoid of tissue except for scattered plaques of friable red/brown material consistent with dried blood components.Histopathological examination was not performed due to the paucity of adherent tissue.The device was subjected to an enzymatic digestion process to remove biologic debris.Following digestion the device was examined for material disruptions with the aid of a stereomicroscope.The stent wire was then focally removed in two regions of the body, and the overlying bonding tape cut, in order to visualize obscured holes.The device was regionally examined using scanning electron microscopy (sem).No other manipulation of the device was performed.There are 21 holes in the device: 7 clustered holes are in the body of the device and 14 clustered holes are scattered circumferentially around proximal manufacturing traction line holes.Four of the body holes likely occurred during the explant procedure.For the remaining 17 holes, the mechanism, the time of occurrence and possible interrelation to other holes is indeterminate.There are no wear related findings.

• 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: helen huang ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6408806
• MDR Text Key: 70060832
• Report Number: 2017233-2017-00129
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 05/15/2017

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: 07/07/2018
• Device Catalogue Number: VBC080502
• Device Lot Number: 14155527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2015
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 74