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

Catalog Number PAJR051502E

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2023

Event Type  Injury  

Event Description

Reportedly the deployment line of the gore® viabahn® endoprosthesis with propaten bioactive surface was stuck after ~ 5cm.No further release possible.Device was removed without problems and a new one was used instead.

Manufacturer Narrative

Patient identifier: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Code 13: further information related to the procedure, the incident and the patient condition was requested from the hospital and were captured in the adverse event description.Code b14: a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.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.

Manufacturer Narrative

B5 and b7: event description and relevant patient history fields were updated.With the obtained information from physician through a company representative, it has been determined this complaint is not deemed reportable.There were no reports of patient harm or broken components.Therefore, manufacturer report # 2017233-2023-03814 will be retracted.

Event Description

The following was reported to gore: on (b)(6) 2023, a patient presented for treatment in the popliteal artery due to recurring in-stent restenosis.During this treatment, a 6fr terumo sheath was used to advance a gore® viabahn® endoprosthesis with propaten bioactive surface (vsx device) to the intended treatment site.Deployment was started and deployment line unraveled about 5cm, then became stuck and no further release was possible.The constrained vsx device was removed with no issues.As reported, the deployment line did not break.A new vsx device was advanced and deployed with no issues.The patient did not experience any adverse consequences.

Manufacturer Narrative

The manufacturing records were reviewed and documented in the product history task.The device lot met all pre-release specifications.The returned device was deemed consistent with the product listed within the complaint.Evaluation of the returned device indicates zipper fiber is bunched between transition an endoprosthesis.Engineering evaluation of the device could confirm the reported failure mode of failure to deploy; deployment line stuck.The source and timing, of the deployment line failure cannot be established through evaluation of the returned device because of differences between conditions seen in the clinical setting and those seen in the laboratory (i.E., patient anatomy, procedural conditions).The manipulation which caused the perceived bunching on the outer zipper could have occurred before, during, or after the procedure.The root cause of the reported failure mode could not be established with the available information.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN 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: wilson okeke ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16609469
• MDR Text Key: 312412889
• Report Number: 2017233-2023-03814
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PAJR051502E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• 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 Age: 78 YR
• Patient Sex: Male