MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number VBH111002A

Device Problem Premature Activation (1484)

Patient Problem Tissue Damage (2104)

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Vbh111002a/ 14149008 udi# (b)(4).The device is not available for analysis.

Event Description

On (b)(6) 2017 a patient was being treated for an unknown etiology, likely in a superficial femoral artery (sfa), with a gore® viabahn® endoprosthesis with heparin bioactive surface (vbh111002a/14149008).An up and over the aortic bifurcation technique was utilized.At some point during advancement of the gore® viabahn® endoprosthesis, the device began deploying, pre-maturely, without initiating deployment with the deployment knob.Device expansion was seen in the trailing end of the stent.Attempts were made to withdraw the partially deployed device and eventually the delivery catheter was cut open.During withdrawal from the patient, some arterial damage was recognized and the patient had an open arterial repair.The patient did well following the procedure.

Manufacturer Narrative

The engineering evaluation stated the following: the catheter was returned in 2 pieces.The first piece consisted of the deployment hub connected to the catheter tubing that measured approximately 109cm.The tubing appeared cut.The deployment knob was still attached to the deployment hub.The second piece consisted of the distal tip, distal shaft upon which the endoprosthesis is mounted, the transition, and a section of the distal catheter tubing that measured approximately 17cm.The endoprosthesis was longitudinally compressed towards the distal tip.Approximately 3cm of the distal shaft was exposed at the transition end.The first strut row on the transition end of the endoprosthesis was outwardly bent.Approximately 4.5cm of the outer braided constraining line was deployed.There was approximately 14.5cm of deployment line between the transition and the endoprosthesis.The remainder of the endoprosthesis was constrained by the braided constraining line.The remainder of the device appeared unremarkable.Based on the device examination performed, no manufacturing anomalies were identified.According to the gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use (ifu), inadvertent, partial, or failed deployment or migration of the endoprosthesis may require surgical intervention.

Event Description

The following information was reported to gore: on (b)(6) 2017 a patient was being treated for an unknown etiology, likely in a superficial femoral artery, but unknown at this time with a gore® viabahn® endoprosthesis with heparin bioactive surface.An up and over the aortic bifurcation technique was utilized.At some point during advancement of the gore® viabahn® endoprosthesis with heparin bioactive surface, the device began deploying, pre-maturely, without initiating deployment with the deployment knob.Device expansion was seen in the trailing end of the stent.Attempts were made to withdraw the partially deployed device and eventually the delivery catheter was cut open.During withdrawal from the patient, some arterial damage was recognized and the patient had an open arterial repair.The patient did well following the procedure.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6611295
• MDR Text Key: 76655380
• Report Number: 2017233-2017-00285
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2018
• Device Catalogue Number: VBH111002A
• Device Lot Number: 14149008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2015
• 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 Outcome(s): Hospitalization; Required Intervention