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

Catalog Number PAH100502B

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Rupture (2208)

Event Date 11/07/2021

Event Type  malfunction  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.

Event Description

The following was reported to gore: on (b)(6) 2021, a gore® viabahn® endoprosthesis was to be placed in the external iliac for treatment of a rupture artery.The patient was admitted to the hospital as a trauma patient with a fractured pelvis.The patient was found to have a ruptured external iliac.A gore® viabahn® endoprosthesis was successfully placed in the external iliac and an additional gore® viabahn® endoprosthesis was successfully placed overlapping the first device, extending into the superficial femoral artery.However, when the physician attempted to removed the deployment line, the physician felt resistance and could not remove the deployment line.After a couple of attempts to remove the deployment line, the decision was made to cut the deployment line at skin level.The patient did not experience any adverse consequences.

Manufacturer Narrative

Section h6 updated to reflect completion of investigation.Manufacturing records were reviewed, and the device met all pre-release specifications.The device remains implanted and was not available for analysis.However, the product investigation of the delivery catheter and deployment line were performed and the following was identified: evaluation of the returned product indicates the deployment line was cut near the transition.The deployment line within the device was unable to be removed from the dual lumen by pulling on the knob.The reported difficulty removing the deployment line is observed during evaluation, but the cause could not be established.The deployment line reportedly was able to be pulled sufficiently to deploy the endoprosthesis during the procedure, and the potential for dried blood within the lumen of the returned delivery system confounds evaluation of deployment line passage.Thus, a failure mode was not able to be confirmed.No new harms, hazardous situations, device failure modes, or causes of failure modes were identified based on this investigation.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12852858
• MDR Text Key: 281520551
• Report Number: 2017233-2021-02556
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: CA
• 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: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2023
• Device Catalogue Number: PAH100502B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 06/08/2022
• Supplement Dates FDA Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1