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

Model Number VBHR060202A

Device Problem Migration (4003)

Patient Problem No Code Available (3191)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2020, the patient presented with an unknown etiology in the renal artery and underwent treatment using a gore® viabahn® endoprosthesis (vsx) and three gore® viabahn® vbx balloon expandable endoprosthesis (vbx).The physician deployed the first vbx device approximately <1 cm shallow in the treatment zone.Then the physician extended the placed endoprosthesis with an additional vbx device.The physician then deployed a vsx device to line both vbx devices.While attempting to remove the rosen guidewire, the wire dislodged all of the stents and pulled the vbx & vsx devices out of the vessel.The physician was then able to snare all three devices and capture the devices for removal with a large bore sheath.A femoral cut down was then used to remove all snared devices from patient.The patient tolerated the procedure.

Manufacturer Narrative

H6 code: 3191- migration from guidewire pulling stents out of vessel and a surgical cut down to remove the stents.Cbas® heparin surface incorporates cbas-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

The following was reported to gore: on (b)(6) 2020, the patient presented with an unknown etiology in the renal artery and underwent treatment using a gore® viabahn® endoprosthesis (vsx) and three gore® viabahn® vbx balloon expandable endoprosthesis (vbx).The physician deployed the first vbx device approximately 1 cm shallow in the treatment zone.Then the physician extended the placed endoprosthesis with an additional vbx device.The physician then deployed a vsx device to line both vbx devices.While attempting to remove the rosen guidewire, the wire dislodged all of the stents and pulled the vbx & vsx devices out of the vessel.The physician was then able to snare all three devices and capture the devices for removal with a large bore sheath.A femoral cut down was then used to remove all snared devices from patient.The patient tolerated the procedure.

Manufacturer Narrative

Patient information was made available and the following fields were updated: a2 - dob: (b)(6) 1937; 83 years old.A3 - female patient information was made available and the following field was corrected.A1 - patient identifier corrected to (b)(6).

• 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
• MDR Report Key: 10491455
• MDR Text Key: 205704548
• Report Number: 2017233-2020-01213
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132622726
• UDI-Public: 00733132622726
• Combination Product (y/n): Y
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2022
• Device Model Number: VBHR060202A
• Device Catalogue Number: VBHR060202A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR