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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP
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W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP Back to Search Results
Catalog Number PAJR051002B
Device Problem Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/08/2020
Event Type  Injury  
Event Description
The following information was reported to gore: on an unknown date, a patient underwent treatment of a superficial femoral artery stenosis with bare metal stents the bare metal stents were believed to be absolute pro stents.A gore® viabahn® endoprosthesis with propaten bioactive surface was used proximally to reline part of the bare metal stent system.On (b)(6) 2020 the patient underwent treatment of in-stent restenosis in the sfa.A 5mm x 25cm gore® viabahn® endoprosthesis with propaten bioactive surface was deployed distally within the bare metal stent.A 5mm x 10cm was then advanced into the first with 1cm overlap.Deployment was initiated, and when it reached deployment half way, approximately 5cm, the deployment line broke.An attempt to retrieve the rest of the deployment line was made by cutting the delivery catheter, however this was not successful.A cutdown procedure was then performed to retrieve the partially expanded device.
 
Manufacturer Narrative
B.5.Updated.H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.H.6.Results code 2: 213: the engineering evaluation stated the following: the endoprosthesis, deployment line, a section of delivery catheter and a guidewire were returned.The guidewire was not evaluated as it is not a gore product.There was approximately 153.3 cm of deployment line attached to the deployment knob including two single fibers measuring approximately 2.8 cm and 0.5 cm.An additional section of the deployment line was attached to the endoprosthesis, measuring approximately 6.4 cm the delivery catheter appeared to be cut.The returned section measured approximately 35cm.Approximately 6.7 cm of the endoprosthesis was expanded.The remainder of the endoprosthesis was constrained by the inner braided constraining line.Deployment was able to be continued with traction on the deployment line at the endoprosthesis.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.
 
Event Description
The following information was reported to gore: on an unknown date, a patient underwent treatment of a superficial femoral artery stenosis with bare metal stents the bare metal stents were believed to be absolute pro stents.A gore® viabahn® endoprosthesis with propaten bioactive surface was used proximally to reline part of the bare metal stent system.On (b)(6) 2020 the patient underwent treatment of in-stent restenosis in the sfa.A 5mm x 25cm gore® viabahn® endoprosthesis with propaten bioactive surface was deployed distally within the bare metal stent.A 5mm x 10cm was then advanced into the first with 1cm overlap.Deployment was initiated, and when it reached deployment half way, approximately 5cm, the deployment line broke.An attempt to retrieve the rest of the deployment line was made by cutting the delivery catheter, however this was not successful.A cutdown procedure was then performed to retrieve the partially expanded device.Sometime after the cut-down procedure, thrombus was identified and a venous patch was placed, followed by groin closure.The patient had a hypertensive episode in the recovery unit which resulted in the groin closure ties coming out.A groin hematoma developed and this was treated with an additional surgical procedure.The patient did well following this treatment.
 
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Brand Name
GORE VIABAHN ENDOPROSTHESIS - 3
Type of Device
NIP
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
MDR Report Key9978791
MDR Text Key188343115
Report Number2017233-2020-00257
Device Sequence Number1
Product Code PFV
Combination Product (y/n)N
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 05/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/08/2022
Device Catalogue NumberPAJR051002B
Device Lot Number21005849
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age86 YR
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