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

Catalog Number JHJR081002J

Device Problem Activation Failure (3270)

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

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

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 Description

On (b)(6) 2024, this patient underwent a percutaneous coronary intervention and a 7 fr sheath was inserted from the right upper limb.During the procedure, bleeding from the right subclavian artery (rsa) was noted and it was determined that iatrogenic vascular injury due to guidewire handling.Therefore, an attempt was made to stop the bleeding by gore® viabahn® endoprosthesis (viabahn device, 8 mm x 10 cm) implantation.When deploying the device, the deployment line got stuck and the device was not expanded.At this time, a treasure floppy (0.018¿) was used as a guidewire.The fsa advised to change the guidewire to a stiffer one; however, the guidewire got stuck in the delivery catheter.Thus, the physician withdrew the guidewire together with the delivery catheter.The guidewire could not be removed from the viabahn device even outside the patient.Another viabahn device (8 mm x 5 cm) was used for the procedure and the bleeding stopped.The patient tolerated the procedure.Reportedly, the patient condition was poor and the procedure was emergency, so sheaths and other devices stocked in the hospital were used.Long sheaths were unavailable for the procedure.

Manufacturer Narrative

Section h6: codes for investigation findings and conclusions have been updated to reflect results of investigation.The engineering evaluation report details observations made directly on the returned device in addition to device photos captured during evaluation.Evaluation of the returned device indicates that it had a guidewire within the guidewire lumen passing from the hub through the distal tip.Evaluation also indicated a fully deployed outer zipper and partial device expansion at the distal end.A bent strut at the proximal end of the endoprosthesis, exposition of the distal shaft at the transition, and damage to the deployment notch at the transition were also observed.The reported failure mode of the catheter and device being stuck on the guidewire is not consistent with the findings of an ability to remove the returned guidewire from the guidewire lumen during engineering evaluation.The reported failure mode of inability to initiate deployment due to a stuck deployment line is not consistent with the findings of an ability to continue deployment of the endoprosthesis with traction at the knob during engineering evaluation.The root cause of the observed outwardly bent strut could not be established with the available information.The root cause of the observed exposition of the distal shaft at the transition could not be established with the available information.The root cause of the observed damage to the deployment notch at the transition could not be established with the available information.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: tatsuya sato ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18947743
• MDR Text Key: 339153477
• Report Number: 2017233-2024-04729
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JHJR081002J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2023
• 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 Outcome(s): Required Intervention
• Patient Sex: Male