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

Catalog Number PAJR061002E

Device Problems No Apparent Adverse Event (3189); Migration (4003)

Patient Problems Fistula (1862); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 Description

On (b)(6) 2022, the patient underwent an endovascular intervention to treat an arteriovenous fistula that was located 2 cm below the femoral bifurcation.The fistula was treated with a gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn device).After placement of the viabahn device it was post-dilated with a percutaneous transluminal angioplasty (pta) balloon (6 fr x 40 mm, medtronic).Reportedly, control imaging at the end of the procedure showed satisfactory results.The patient was discharged home at the same day.On (b)(6) 2022, the patient presented at the cardiologist, who discovered that the viabahn device has migrated downwards at mid-thigh by several centimeters.The same day, the patient underwent an endovascular reintervention because of the migration.To recover the migration a pta balloon (6 fr inflation, medtronic) was used to track the migrated viabahn device back to the level of the arteriovenous fistula.Then a second viabahn device was implanted as a proximal extension of the first viabahn device.Reportedly, control imaging at the end of the procedure showed satisfactory results.It was reported that the cause for the migration of the viabahn device most likely was a sizing issue.The physician said that in the present case the initially used viabahn device was too small.It was further reported that the intima of the femoral artery was smooth with no calcified plaques present.The physician suspects that this also could have contributed to the migration of the viabahn device.

Manufacturer Narrative

Additional received information determined that this event is not reportable to the fda and therefore the medwatch is retracted.Cause investigation and conclusion a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Pre-implant, intra-procedural and post implant images were requested from the hospital for evaluation.Images could not be shared with gore, because images were not saved.Therefore, an imaging evaluation could not be performed.Detailed information was requested, but no information related to vessel sizing or measurement was provided.The endoprosthesis remains implanted, therefore, an evaluation of the actual device could not be performed.The delivery catheter with distal shaft and hub was returned for evaluation.The evaluation summary states the following: the reported device migration could not be independently confirmed.The device was returned without the endoprosthesis, and this is consistent with the reported event.The observation of device sizing is consistent with the reported complaint.Further information was provided by the physician, indicating that the reported device did not migrate.Reported serial number and returned delivery catheter belong to the second device that was implanted as a proximal extension of the first device.The second device did not show migration.Therefore this report related to reported serial number (b)(6) turned into a non-reportable incident.Please refer to the manufacturer incident report with gore reference number (b)(4), mfr report 2017233-2022-03603, for the first device that is reported to have migrated.

Event Description

On (b)(6) 2022, the patient underwent an endovascular intervention to treat an arteriovenous fistula that was located 2 cm below the femoral bifurcation.The fistula was treated with a gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn device).After placement of the viabahn device it was post-dilated with a percutaneous transluminal angioplasty (pta) balloon (6 fr x 40 mm, medtronic).Reportedly, control imaging at the end of the procedure showed satisfactory results.The patient was discharged home at the same day.On (b)(6) 2022, the patient presented at the cardiologist, who discovered that the viabahn device has migrated downwards at mid-thigh by several centimeters.The same day, the patient underwent an endovascular reintervention because of the migration.To recover the migration a pta balloon (6 fr inflation, medtronic) was used to track the migrated viabahn device back to the level of the arteriovenous fistula.Then a second viabahn device was implanted as a proximal extension of the first viabahn device.Reportedly, control imaging at the end of the procedure showed satisfactory results.It was reported that the cause for the migration of the viabahn device most likely was a sizing issue.The physician said that in the present case the initially used viabahn device was too small.It was further reported that the intima of the femoral artery was smooth with no calcified plaques present.The physician suspects that this also could have contributed to the migration of the viabahn device.

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15870952
• MDR Text Key: 304425363
• Report Number: 2017233-2022-03512
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2023
• Device Catalogue Number: PAJR061002E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 12/22/2022
• Supplement Dates FDA Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2020
• 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; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Male