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

Catalog Number VBH130502W

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

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

Event Date 06/14/2019

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 on (b)(6) , 2019, the patient was treated for a type a dissection.The physician did a total arch replacement.A 13 mm x 5 cm gore® viabahn® endoprosthesis with heparin bioactive surface was to be implanted to bridge the innominate artery and a branch of ascending graft without fluoroscopy but under eyesight via 0.035 inch 260 cm terumo soft wire.After the device was advanced to the target lesion, the physician didn't feel any resistance at the beginning(first zip) when he pulled the deployment line.The device deployment was not under fluoroscopy, so the physician wanted to deploy quickly.Then the deployment line was broken.The physician tried to retract the delivery system, but the delivery system could not be retracted.The physician cut the delivery catheter and found the device was no full expansion.He released a distal anastomosis which was on aortic prosthesis graft and innominate prosthesis junction, then took out the partial deployed device.Another gore® viabahn® endoprosthesis with heparin bioactive surface was implanted to complete the procedure.The new device was able to deploy successfully.The patient did not experience any adverse consequences.

Manufacturer Narrative

H6:code 213-an engineering evaluation was performed on the returned device.The evaluation results stated that the endoprothesis, deployment knob, deployment line, the distal tip, and part of the distal shaft, upon which the endoprosthesis is mounted, were returned.The deployment line appeared to be broken with one section attached to the deployment knob and another section attached to the inner braided constraining line on the endoprothesis.Two single fibers measuring approximately 1.5cm were attached near the constrained end of the endoprothesis.One single fiber measuring approximately 5cm was attached to the tip end of the endoprothesis.The inner braided constraining line was deployed approximately 3.5cm.Approximately 2cm of the endoprothesis remained constrained.Deployment was not able to be continued with traction on the deployment line at the endoprosthesis.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8783817
• MDR Text Key: 150996111
• Report Number: 2017233-2019-00521
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2022
• Device Catalogue Number: VBH130502W
• Device Lot Number: 20411100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 80