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

Catalog Number VBHR080202W

Device Problem Material Fragmentation (1261)

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

Event Date 10/12/2023

Event Type  malfunction  

Event Description

The following was reported to gore: on (b)(6) 2023, a patient was implanted with 8mm x 2.5cm gore® viabahn endoprosthesis with heparin bioactive surface (viabahn device) to reconstruct of renal artery during abdominal artery aneurysm procedure.When the physician advanced viabahn device, it was stuck at the entry of the left renal artery and couldn't be moved forward or retracted.The aortic stent was pre-existing.Since the angle was too large (almost right angle), the catheter was unable to move up and down after multiple attempts.When withdrawing catheter with big force, the delivery system near endoprosthesis was broken.The separated components couldn't be removed together.After the endoprosthesis was deployed, the catheter could be retracted.The distal shaft was missing after removal.Under radiography, the distal shaft wasn¿t inside the patient.It was suspected that the distal tip was stuck in sheath during removal.There was no injury to the patient.The patient tolerated the procedure.The sheath was discarded.

Manufacturer Narrative

H6: c19- a review of the manufacturing records indicated the device met pre-release specifications.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.

Manufacturer Narrative

H6: c19- the returned device was determined to be consistent with the product listed within the complaint by means of labelling and device features.The dual lumen catheter with transition was returned with attached hub assembly, deployment knob, and a section of broken deployment line visible at the transition.The endoprosthesis, distal shaft, and distal tip were not returned for analysis.The returned dual lumen catheter with transition was evaluated for the presence of a bond at the site of distal shaft detachment.Material at the end of the dual lumen indicated a bond was successfully executed.No further analysis was possible concerning the reported device failures with the items returned for evaluation.D1102 - the reported separation of components was confirmed from evaluation of items in the condition received.The delivery system assembly was returned incomplete with missing distal shaft and distal tip.The distal shaft bonding site was evaluated, and material at the end of the dual lumen indicated a bond was successfully executed.The field reports withdrawing the catheter with ¿big force.¿ excessive or abrupt force during catheter removal is consistent with damage to the delivery system.Therefore, the root cause of the broken components is consistent with use error as reported (i.E., delivery catheter is withdrawn forcefully).

• 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: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18063466
• MDR Text Key: 327259103
• Report Number: 2017233-2023-04378
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VBHR080202W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2023
• 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 Age: 68 YR
• Patient Sex: Male