MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number JHJR051002J

Device Problem Failure to Eject (4010)

Patient Problem Occlusion (1984)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional manufacturer narrative: cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

On (b)(6) 2020, this patient underwent endovascular treatment for a chronic occlusive lesion in the right superficial femoral artery, and was implanted with gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn).The first viabahn was deployed without any reported issue.A second viabahn was advanced, and during deployment after approximately 2cm of the tip had deployed the physician was unable to pull the deployment knob any further.The physician attempted to fully deploy, twisting the device left and right, and moving the shaft back and forth, but it was not successful.The physician chose to withdraw the device back within the sheath, and it was removed from the patient.A new viabahn was deployed without issue, and the procedure was concluded.The patient tolerated the procedure.The device will be returned to gore for analysis, and the results will be provided in a supplemental medwatch.

Manufacturer Narrative

H3/h6: the engineering evaluation confirms a partially deployed device, and the cause of partial deployment is attributed to a stuck deployment line.Tension applied to the stuck deployment line was sufficient to initiate damage to the line.The stuck deployment line is considered related to a broken slip knot row where deployment stopped, and the cause of the broken knot row cannot be established.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10687255
• MDR Text Key: 211667849
• Report Number: 2017233-2020-01355
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• PMA/PMN Number: P040037 P130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2021
• Device Catalogue Number: JHJR051002J
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 10/07/2020
• Supplement Dates FDA Received: 03/10/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 73 YR
• Patient Weight: 53