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

Catalog Number JHJR052502J

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Stenosis (2263)

Event Date 03/07/2019

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: review of the manufacturing records indicated the device met pre-release specifications.The investigation is ongoing.

Event Description

On (b)(6) 2019, the patient underwent endovascular procedure using a gore® viabahn® endoprosthesis to repair in-stent restenosis of the left superficial femoral artery.It was reported that after pre-dilation, a 6fr.Introducer sheath was advanced over the target lesion.The delivery catheter was advanced ipsilaterally to the intended position with no reported issues.During deployment, it was noted that most of the gore® viabahn® endoprosthesis(except 3-4cm from the tip) deployed within the sheath.The physician removed the deployed device from the patient using cut-down technique.The procedure was concluded using another gore® viabahn® endoprostheses with no further issues.The patient tolerated the procedure.It was reported that the sheath was not pulled back enough prior to the deployment of the device.The delivery catheter of the jhjr052502j/20086526 will be returned to gore for evaluation.A response letter to the physician is not requested.

Manufacturer Narrative

Additional manufacturer narrative: examination of the returned device revealed the following: the endoprosthesis and part of the delivery catheter were returned; there was no hub, deployment knob, or distal end of the delivery catheter returned; the cut section of delivery catheter was approximately 20.5 cm long; the diameter of the delivery catheter appeared stretched and expanded; the body of the delivery catheter appeared to be damaged; there was approximately 2 cm of the endoprosthesis coming out of the delivery catheter, the remainder of the endoprosthesis remained within the lumen of the delivery catheter; the endoprosthesis appeared damaged with nitinol wire coming off of the endoprosthesis.Based on the device examination performed, no manufacturing anomalies were identified.Corrected data: results code #2.Conclusion code #1.

Manufacturer Narrative

Additional manufacturer narrative: combination product.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8474767
• MDR Text Key: 140668858
• Report Number: 2017233-2019-00203
• 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: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2021
• Device Catalogue Number: JHJR052502J
• Device Lot Number: 20086526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention