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

Catalog Number JHJR061002J

Device Problems Entrapment of Device (1212); Activation Failure (3270)

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

Event Date 01/05/2022

Event Type  malfunction  

Event Description

The following information was reported to gore: on (b)(6) 2022, this patient underwent endovascular procedure to treat a left superficial femoral artery occlusion using two drug-eluting stents (des, eluvia¿).When deploying the second des, the proximal part of the stent was deployed in the sheath unintentionally.The sheath was pulled without realizing that the proximal part of the des was deployed in the sheath, resulting in proximal migration of the des.Furthermore, the stent shrank and distorted during this process.Reportedly, mural thrombus was observed in the patient's vessel.For repair, a gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) was used to reline the des.During the deployment of the viabahn device, the deployment line was caught by the stent of the des, resulting in incomplete deployment.The stent graft could not be fully deployed by moving the delivery catheter back and forth, and the viabahn device was removed with the sheath.At that time, the previously implanted two dess were also removed together.It was confirmed that a part of vessel intima was peeled by the des.The procedure was completed by implanting a new stent graft in the injured site.The patient tolerated the procedure.

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Manufacturer Narrative

The japan ifu for this product states: deployment of this product: do not deploy this product within stents or stent grafts other than this product.[there is a possibility that this product may not advance through a previously implanted stent, or that stent may interrupt deployment of this product].Gore requested further information regarding this procedure, including device serial number; however no further information has been reported to gore, therefore this investigation is considered complete.

Manufacturer Narrative

No device was returned to gore for evaluation.One photograph was returned to gore showing the removed viabahn device partially expanded within another stent.This supports the reported event of the deployment line becoming caught on an existing non-gore stent.

• 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: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13365899
• MDR Text Key: 284811352
• Report Number: 2017233-2022-02692
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2022

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 Operator: Health Professional
• Device Catalogue Number: JHJR061002J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 01/27/2022
• Supplement Dates Manufacturer Received: 05/02/2022; 05/02/2022
• Supplement Dates FDA Received: 05/03/2022; 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 76 YR
• Patient Sex: Male