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

Device Problem Insufficient Information (3190)

Patient Problem Pseudoaneurysm (2605)

Event Date 01/11/2020

Event Type  Injury  

Manufacturer Narrative

Due to an unknown lot/serial number and no device return, an investigation could not be performed and confirmed the cause of the reported issue for this event.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 received through literature ¿surgical management of axillary artery aneurysms with endovascular stenting versus open repair: a report of two cases and literature review¿ published by catheter cardiovasc interv.2020; 95:1163¿1168.The study was to evaluate axillary artery aneurysms necessitate repair against conventional open repair, with increasing endovascular interventions for these uncommon lesions.The results state in case 2, a 65-year-old gentleman presented with a one-day history of increasing pain over his left arm, with no other neurological deficit.On (b)(6) 2017, placement of a 6 × 50 mm viabahn (w.L.Gore & associates, flagstaff, az) stent graft across the aneurysm was performed (fig.5).On postoperative day 1, the patient developed a tender, edematous left upper limb with an ultrasound arterial doppler scan revealing a new left brachial pseudoaneurysm measuring 16 × 7 mm with a short wide neck of 2 mm at the site of previous arterial puncture.Attempts of ultrasound-guided compression and bandaging failed to resolve the pseudoaneurysm.The patient then underwent a second operation for open repair and hemostasis of the left brachial artery pseudoaneurysm.After the second repair, the patient had no further complaints of his left upper limb and was discharged on postoperative day 7.

Manufacturer Narrative

Citation: sher-lyn tham, yuxin guo, maria cui-ying pang, jack kian chng, surgical management of axillary artery aneurysms with endovascular stenting versus open repair: a report of two cases and literature review, annals of vascular surgery, volume 58, 2019, pages 385.E11-385.E16, issn 0890-5096, https://doi.Org/10.1016/j.Avsg.2018.11.010.

Event Description

The following information was received through literature ¿surgical management of axillary artery aneurysms with endovascular stenting versus open repair: a report of two cases and literature review¿ published by annals of vascular surgery, volume 58, 2019, pages 385.E11-385.E16.The study was to evaluate axillary artery aneurysms necessitate repair against conventional open repair, with increasing endovascular interventions for these uncommon lesions.The results state in case 2, a 65-year-old gentleman presented with a one-day history of increasing pain over his left arm, with no other neurological deficit.On (b)(6) 2017, placement of a 6 × 50 mm viabahn (w.L.Gore & associates, flagstaff, az) stent graft across the aneurysm was performed (fig.5).On postoperative day 1, the patient developed a tender, edematous left upper limb with an ultrasound arterial doppler scan revealing a new left brachial pseudoaneurysm measuring 16 × 7 mm with a short wide neck of 2 mm at the site of previous arterial puncture.Attempts of ultrasound-guided compression and bandaging failed to resolve the pseudoaneurysm.The patient then underwent a second operation for open repair and hemostasis of the left brachial artery pseudoaneurysm.After the second repair, the patient had no further complaints of his left upper limb and was discharged on postoperative day 7.

• 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: 14953729
• MDR Text Key: 295477139
• Report Number: 2017233-2022-03102
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: SN
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 07/20/2022
• Supplement Dates FDA Received: 08/01/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male