MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number VBH111002W

Device Problems Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.Per gore® viabahn® endoprosthesis instructions for use (ifu), w.L.Gore & associates acknowledges that during introduction and positioning of the gore® viabahn® endoprosthesis, advance cautiously, especially if resistance is felt.If excessive resistance is felt, remove the delivery catheter and sheath together.It is stated that complications and adverse events that can occur when using any endovascular device.These complications include but are not limited to deployment failure.A warning is given as ¿inadvertent, partial, or failed deployment of the endoprosthesis may require surgical intervention.¿.

Event Description

It was reported to gore that a 11mm x 10cm gore® viabahn® endoprosthesis was to be implanted for treatment of an iliac artery aneurysm.After the device was advanced to the target lesion, the physician initiated the deployment line and two thirds of the device was deployed.Then a resistance was reportedly felt, the endoprosthesis could not be deployed further.The deployment line was broke when excessive force was used.The distal tip of the endoprosthesis was expanded only 40 percent of the normal diameter.When the physician attempted to retract the catheter, resistance was encountered, the endoprosthesis dislodged and caused an endoleak.The endoprosthesis could not be withdrawn so it was left in patient's vessel.A new gore® viabahn® endoprosthesis of 13mm x 10cm was used to continue the procedure successfully.The device was crushed against the patient's vessel using a 13 x 10 viabahn device.The patient tolerated the procedure.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• 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: vickie lang ; 9285263030
• MDR Report Key: 8423570
• MDR Text Key: 138937689
• Report Number: 2017233-2019-00148
• 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: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2019

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: 09/18/2021
• Device Catalogue Number: VBH111002W
• Device Lot Number: 18805365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2018
• 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 Age: 54 YR
• Patient Weight: 65