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

Catalog Number JHHR101002J

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Shock (2072); Perforation of Vessels (2135)

Event Date 08/26/2022

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

The following information was reported to gore: on (b)(6) 2022, this patient underwent endovascular treatment using gore® dryseal flex introducer sheath for descending thoracic aortic aneurysm.For the right common femoral artery approach, an attempt was made to insert only the dilator of dsf2233, but there was significant resistance.It was decided to perform endo-conduit from the left side.A gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn) that had been placed earlier in the procedure was dilated with a balloon catheter and the dsf1833 was replaced with dsf2233 and inserted.It was reported that the viabahn may have been pushed up when operating dsf2233, which resulted in an access vessel injury at the distal edge of the viabahn device, and the patient went into shock.Two additional viabahn were deployed and vitals recovered.The cfa approach was abandoned, the approach was changed again to the abdominal aorta.Tevar was completed without endoleak.Reportedly, the abdominal aorta was replaced.The physician stated as follows: the possibility of access injury was recognized.The plan was a right cfa approach, but a left approach was chosen because severe stenosis was also observed at the right cia origin.

• 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: 15414142
• MDR Text Key: 299813081
• Report Number: 2017233-2022-03312
• 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
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JHHR101002J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• Date Device Manufactured: 08/31/2021
• 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 Age: 83 YR
• Patient Sex: Male