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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 PAH131002E
Device Problems Break (1069); Separation Failure (2547); Difficult or Delayed Activation (2577)
Patient Problem No Code Available (3191)
Event Date 03/19/2019
Event Type  malfunction  
Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
 
Event Description
On unknown date the patient underwent an axillo-bi-femoral bypass procedure using unknown endovascular grafts.On unknown date the patient presented with a pseudoaneurysm at the anastomosis, site unknown.It was reported to gore that it was intended to re-line the axillo-bi-femoral bypass using a gore® viabahn® endoprosthesis with heparin bioactive surface to treat the pseudoaneurysm.The viabahn® device was advanced using a rosen guidewire.Reportedly an issue with the deployment mechanism was noticed.The viabahn® endoprosthesis initially did not fully deploy, but then eventually did so by unknown action.It was stated that not all the deployment line was retrieved from the patient.
 
Event Description
On unknown date the patient underwent an axillo-bi-femoral bypass procedure using unknown endovascular grafts.On unknown date the patient presented with a pseudoaneurysm at the anastomosis, site unknown.It was reported to gore that it was intended to re-line the axillo-bi-femoral bypass using a gore® viabahn® endoprosthesis with heparin bioactive surface to treat the pseudoaneurysm.The viabahn® device was advanced using a rosen guidewire.Reportedly an issue with the deployment mechanism was noticed.The viabahn® endoprosthesis initially did not fully deploy.The deployment line was pulled until it could not be pulled further.Reportedly eventually the viabahn deployed slowly after this time as if on a time lag.It was reported to gore that the deployment line didn´t detach from the deployed viabahn® endoprosthesis.The deployment line was pulled as hard as possible without dislodging the viabahn® endoprosthesis.Eventually the deployment line snapped and the delivery system could be removed from the patient.It was stated that not all the deployment line was retrieved from the patient.Reportedly the patient has suffered no sequelae from this event although a part of the deployment line is still within the axillo-femoral graft.
 
Manufacturer Narrative
A: updated patient information b5: updated event description g5: correction: combination product: yes (b)(4).The first piece measured 110 cm while the second piece measured 113 cm.On the second piece of broken deployment line, there were several sections of single fiber.On one end, there was a fiber that measured approximately 4 cm, there was another single fiber in the middle that measured 20 cm.There were two single fibers at the other end of the second piece that measured approximately 20 and 14 cm.The remainder of the device was unremarkable.Based on the device examination performed, no manufacturing anomalies were identified.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 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 an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.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.
 
Manufacturer Narrative
Ld10 - correction: device available for investigation: yes, returned to manufacturer (b)(6) 2019 remark: the endoprosthesis remains in the patient.Delivery catheter and deployment line were returned for investigation.H3 - correction: device evaluated by the manufacturer: yes remark: the endoprosthesis remains in the patient.Delivery catheter and deployment line were returned for investigation.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 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 an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.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 - 3
Type of Device
NIP
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
MDR Report Key8491552
MDR Text Key145640338
Report Number2017233-2019-00225
Device Sequence Number1
Product Code PFV
Combination Product (y/n)N
PMA/PMN Number
P130006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 07/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/05/2021
Device Catalogue NumberPAH131002E
Device Lot Number18672091
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2019
Was the Report Sent to FDA? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age67 YR
Patient Weight90
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