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

Catalog Number JHH130502J

Device Problems Break (1069); Off-Label Use (1494); Activation Failure (3270)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Code 22: according to the gore® viabahn® endoprostheses instructions for use (ifu), although rare, complications and adverse events such as deployment failure may occur.(b)(4).

Event Description

On (b)(6) 2018, the patient underwent an endovascular procedure using a gore® viabahn® endoprostheses for an iatrogenic damage of left iliac artery.The first endoprosthesis was deployed without any trouble.The second endoprosthesis (jhh130502j/16547241) was advanced to the correct position and deployment was initiated.However, post deployment the physician attempted to withdraw the delivery catheter but it seemed the deployment line was stuck.Therefore, the deployment knob was cut off from outside the patient, and the delivery catheter was able to be withdrawn.The remaining deployment line was able to be withdrawn from the patient, but it was thought that fragments from the distal end might have remained in the patient.A third endoprosthesis was implanted between previous two endoprostheses in order to prevent endoleak.The physician commented that the handling of the delivery catheter was done as usual.The patient tolerated the procedure.Tortuous vessels were reported.

Manufacturer Narrative

Additional manufacturer narrative/corrected data: patient identifier, type of reportable event.

Manufacturer Narrative

Engineering evaluation - the following observations were made: no endoprosthesis was returned.The deployment knob was unscrewed from the hub, with approximately 1 cm of deployment line between the hub and knob.There was 1.5 cm of complete deployment line coming from the transition with one fiber extending another 1 cm.The end of the deployment line appeared cut or broken.Engineering evaluation conclusions are: deployment line broken.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7323770
• MDR Text Key: 102110367
• Report Number: 2017233-2018-00155
• 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: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2020
• Device Catalogue Number: JHH130502J
• Device Lot Number: 16547241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other