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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY
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W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Catalog Number JHJR052502J
Device Problem Activation Failure (3270)
Patient Problems Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/17/2020
Event Type  Injury  
Manufacturer Narrative
Investigation still in progress.A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.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
The following was reported to gore: on (b)(6) 2020, the patient underwent endovascular procedure to treat chronic total occlusion of the right superficial femoral artery using a gore® viabahn® endoprosthesis with heparin bioactive surface.Pre-ballooning was performed using a balloon catheter (ultraverse, 4 x 100).A sheath (destination, 6fr, 45cm) was inserted from the contralateral side (left), and the delivery catheter of the gore® viabahn® endoprosthesis with heparin bioactive surface was advanced to the intended position.After a guidewire was exchanged, the physician kept the catheter and another physician started to pull the deployment knob.When around 5cm of the endoprosthesis was deployed, the physician was unable to pull the deployment line.The delivery catheter was moved back and forth, but the deployment was not achieved.The deployment line was broken when the line was forcefully pulled.The physician pulled the catheter, and the position of the endoprosthesis migrated proximally.A sheath (4.5fr) was inserted from the ipsilateral (right) common femoral artery, and balloon catheters (ikazuchi, 4 x 100 and ultraverse) were utilized to expand the stuck portion of the endoprosthesis.However, it was unsuccessful.The physician concluded the procedure while leaving the delivery catheter with the sheath.After discussion with a surgeon, it was decided to perform surgical procedure next day.A surgical procedure to remove the delivery catheter with the partially deployed endoprosthesis and femoropopliteal bypass procedure will be performed on (b)(6) 2020.
 
Event Description
The following was reported to gore: on (b)(6) 2020, the patient underwent endovascular procedure to treat chronic total occlusion of the right superficial femoral artery using a gore® viabahn® endoprosthesis with heparin bioactive surface.Pre-ballooning was performed using a balloon catheter (ultraverse, 4 x 100).A sheath (destination, 6fr, 45cm) was inserted from the contralateral side (left), and the delivery catheter of the gore® viabahn® endoprosthesis with heparin bioactive surface was advanced to the intended position.After a guidewire was exchanged, the physician kept the catheter and another physician started to pull the deployment knob.When around 5cm of the endoprosthesis was deployed, the physician was unable to pull the deployment line.The delivery catheter was moved back and forth, but the deployment was not achieved.The deployment line was broken when the line was forcefully pulled.The physician pulled the catheter, and the position of the endoprosthesis migrated proximally.A sheath (4.5fr) was inserted from the ipsilateral (right) common femoral artery, and balloon catheters (ikazuchi, 4 x 100 and ultraverse) were utilized to expand the stuck portion of the endoprosthesis.However, it was unsuccessful.The physician concluded the procedure while leaving the delivery catheter with the sheath.After discussion with a surgeon, it was decided to perform surgical procedure next day.A surgical procedure to remove the delivery catheter with the partially deployed endoprosthesis and femoropopliteal bypass procedure was performed on (b)(6) 2020.
 
Manufacturer Narrative
H6 clinical code: 4581- appropriate clinical signs, symptoms, conditions term/code not available: femoropopliteal bypass procedure.Imaging evaluation: one time-point available for evaluation: intra-operative angiogram dated (b)(6) 2020.There appears to be a partially deployed device within the left superficial femoral artery.Radiopaque markers appear to be located just distal to the left sfa/profunda bifurcation.Contrast is visualized flowing into the portion of sfa that contains the non-deployed device.H6 result code: 4247: -appropriate term/code not available: engineering evaluation: the following observations were made: the endoprosthesis, delivery catheter, part of the deployment line, and a tuohy-borst adapter was returned.The adapter was not evaluated as it is not a gore product.The delivery catheter was returned in two pieces and appeared to be broken 98 cm from the hub.There was approximately 1 cm of the transition still attached to the distal shaft, upon which the endoprosthesis is mounted.The distal shaft was kinked at the transition and was exposed approximately 0.3 cm near the tip end of the device.The endoprosthesis was longitudinally compressed towards the transition.The endprosthesis was partially expanded approximately 5 cm near the tip end of the device.The inner braided constraining line appeared to be twisted reletive to the deployment notch on the transition.The inner braided constraining line appeared to be bunched where deployment stopped.There was a single fiber coming from the bunched constraining line that was approximately 0.1 cm.Deployment could not be continued with traction on the deployment line at the endoprosthesis.With manipulation, the piece of fiber was able to be removed and was approximately 0.3 cm long.The deployment line was inspected for breaks around where the single fiber was located and no deployment line breaks were identified.Deployment was able to be continued with traction on the deployment line at the endoprosthesis after the single fiber was removed.Further investigation is planned.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
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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
MDR Report Key10399274
MDR Text Key203108418
Report Number2017233-2020-01121
Device Sequence Number1
Product Code NIP
Combination Product (y/n)Y
PMA/PMN Number
P040037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/28/2022
Device Catalogue NumberJHJR052502J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2020
Date Manufacturer Received07/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age85 YR
Patient Weight58
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