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

Catalog Number	VBJR060502A
Medical Device Problem Codes	Activation Failure (3270); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following patient information was asked to the physician but was not available: initials, gender, age, weight, date of birth, comorbidities, medications.A1 - patient identifier; this is an internally generated number.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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.
Event or Problem Description
On (b)(6) 2024, a patient underwent treatment for an aneurysm where a 6 mm x 5 cm gore® viabahn® endoprosthesis (gore® viabahn® device) was intended to be used in the splenic artery.It was reported the physician advanced the delivery catheter through extremely tortuous anatomy using a 6.5f destino steerable sheath over an unknown size platinum plus guidewire to the target treatment zone.It was reported the delivery catheter was advanced without resistance.Reportedly, during deployment, the line was pulled and became stuck.The tip of the catheter was moving too much due to the tugging of the line, and deployment was aborted.The physician withdrew the catheter, with the endoprosthesis fully constrained.It was reported the deployment line did not break.The physician suspects the tortuosity made it difficult to deploy the endoprosthesis.The procedure was completed using a different 6 mm x 5 cm gore®viabahn® device.It was reported there was no impact to the patient.
Additional Manufacturer Narrative
Updated codes based investigation and the results.A review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications product return evaluation: the primary reported device failure mode, the inability to deploy the device due to a stuck deployment line, could not be independently confirmed through engineering evaluation of the returned device.The reported failure mode is consistent with the state of the returned device: the deployment knob was not attached at the hub and deployment had been initiated but not completed.The device was returned with a partially expanded endoprosthesis, but the reported information indicates the device was withdrawn from the patient in a fully constrained state.The manner by which the device deployment continued thereby partially expanding the endoprosthesis could not be established.The deployment line itself was not confirmed to be stuck as deployment using the deployment knob was able to continue during evaluation.The physician attributed the stuck deployment line to tortuous patient anatomy, but the specific cause for the inability to deploy the device as reported during the procedure could not be established with the available information.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Common Device Name: 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20517800
• Report Number: 2017233-2024-05428
• Device Sequence Number: 18302408
• Product Code: NIP
• UDI-Device Identifier: 00733132623952
• UDI-Public: 00733132623952
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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 Catalogue Number: VBJR060502A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown