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

Catalog Number VBC101002

Device Problems Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lot/serial: 17285124= (b)(4).The concomitant medical product was a gore® viabahn® endoprostheses (vbc101002/17285124).The therapy date was (b)(6) 2018.Udi information of the concomitant medical product as following.Lot/serial: 17243393= (b)(4).

Event Description

It was reported to gore that a patient was implanted with abdominal endoprosthesis before and in this procedure was to be treated the bilateral iliac artery aneurysm.For the left iliac artery aneurysm, the physician decided a sandwich technique in the left side, implanting a lifetech abdominal extension stent in the left common iliac artery firstly, then extending parallel with two gore® viabahn® endoprostheses, one into the left internal iliac artery and the other into the left external iliac artery.A 10 mm x 10 cm gore® viabahn® endoprosthesis was inserted from the left brachial artery and advanced to the left internal iliac artery.Next, an 11 mm x 10 cm gore® viabahn® endoprosthesis was inserted from the left femoral artery and advanced to the left external iliac artery.After deployment of the lifetech abdominal extension stent, the physician started to deploy the 10 mm x 10 cm gore® viabahn® device in the left internal iliac artery.When there was still 1 cm of endoprosthesis not yet expanded, the physician started to deploy the 11 mm x 10 cm viabahn device in the left external iliac artery.It was stated that the physician thought both viabahn devices were deployed completely.The catheter of 11 mm x 10 cm viabahn® device was able to retract smoothly.However the retraction of catheter of 10 mm x 10 cm viabahn® device from the left brachial artery was initiated, even though its deployment line was not completely released from the catheter.When the catheter was retracted from the above, the two viabahn endoprostheses and the lifetech abdominal extension stent were pulled proximally into the descending aorta.During retraction of the catheter of 10 mm x 10 cm viabahn® device from the left brachial artery, the deployment line was not able to release from the catheter, so the physician cut the deployment line and the line fragments remained in the patient.For three migrated devices, the physician used a bare metal stent to pin them against the vessel wall.The procedure ended, with plans to follow up a later date.As reported, the patient was stable condition with no reported injury at the time of this report.

• 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: helen huang ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7240323
• MDR Text Key: 99320556
• Report Number: 2017233-2018-00074
• Device Sequence Number: 1
• Product Code: PFV
• 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
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2020
• Device Catalogue Number: VBC101002
• Device Lot Number: 17285124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2017
• 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): Other
• Patient Age: 50 YR