MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Catalog Number BXA083902A

Device Problem Deflation Problem (1149)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

The following was reported to gore: patient presented with a previously implanted fenestrated cook graft that had migrated.As reported, the physician-modified graft was implanted in 2018 or 2019 (specific dates unavailable).On (b)(6) 2022, a new physician-modified graft was implanted to reline the previously implanted graft (unspecified manufacturer) that had slipped out of place.An 8 x 39 gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was placed and deployed in the patient's superior mesenteric artery.The vbx balloon was expanded with no issues.After deployment, the vbx balloon could not be deflated.Physician inflated and deflated the balloon multiple times while manipulating the sheath.As reported, only one inflation device was used; physician also attempted to use different syringes to try and deflate the balloon.Ultimately, the balloon was able to be deflated, pulled back through the sheath and removed from patient's body.The patient did not experience any adverse consequences.After removal, the physician tested the inflation/deflation of the balloon on the back table using the inflation devices and syringes.The balloon was not able to deflate, and it was thought there was possible inflation lumen blockage.

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Patient age/dob, gender, weight, and relevant medical history including medications, were requested but not made available.Device lot/serial number was requested but not made available.Stent was deployed with no issues and remains implanted.The returned components was a mostly deflated balloon and catheter.Engineering evaluation state, evaluation of the returned device confirms the reported failure mode of difficulty deflating the balloon.The cause for this balloon deflation difficulty is attributed to a blockage in the balloon inflation lumen.(b)(4) (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 - b14: device lot/serial number was obtained.Review of device manufacturing record history confirmed device met pre-release specifications.A1, a2 and a3 were populated with obtained patient information.

Manufacturer Narrative

H6: investigation conclusions code was updated to reflect only one code (d02).

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15433275
• MDR Text Key: 300343457
• Report Number: 2017233-2022-03323
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXA083902A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• 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: 72 YR
• Patient Sex: Male