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

Device Problems Material Invagination (1336); Difficult or Delayed Activation (2577)

Patient Problems Pain (1994); Stenosis (2263)

Event Date 07/27/2022

Event Type  malfunction  

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.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 literature was reviewed: 'intravascular lithotripsy for severe calcium-mediated peripheral vascular stent underexpansion' corresponding authors; luai tabaza, hafeez ul hassan, sean janzer, jon c.George.A 79-year-old-male presented with two-month history of right lower extremity rest pain and toe ulceration consistent with rutherford class 5 symptoms.Ankle brachia! index (ab!) study showed monophasic wave forms suggestive of moderate to severe arterial occlusive disease in the right lower extremity at rest with findings of severe inflow disease, femoro-popliteal disease, and small vessel disease in the foot.He was sub­sequently referred for urgent peripheral angiography and intervention.Access was obtained in the left common femoral artery (cfa) using a micropuncture access kit (cook medical, bloomington, in), and place­ment of a 6 fr sheath.A contra catheter (boston scientific, marlborough, ma) was advanced over a glidewire (terumo lnterventional systems, somerset, nj) across the aorto-iliac bifurcation into the right cfa.Selec­tive angiography revealed a heavily calcified occlusion in the mid super­ficial femoral artery (sfa) with reconstitution in the popliteal artery (pa) via the profunda femoris artery (pfa) and a single runoff vessel below the knee via the peroneal artery.Wire crossing was attempted using a stiff glidewire (terumo inter­ventional systems) but was unable to penetrate the sfa chronic total occlusion ( cto) proximal cap.A pacific 5.0 x 120 mm balloon (medtronic inc., fridley, mn) was used to pre-dilate the right sfa lesion with reasonable expansion.An angiosculpt 7.0 x 40 mm scoring balloon (philips, andover, ma) was used to perform additional scoring balloon angioplasty with persistent under-expansion.However, subsequent angiogram revealed mild ex­travasation of contrast at the site of the mid calcified sfa with persistent recoil and under-expansion.The extravasation persisted despite prolonged balloon angioplasty and a viabahn 7.0 x 100 mm covered stent (gore medical, newark, de) was deployed in the mid right sfa and post-dilated using the pacific 5.0 x 120 mm balloon with good ex­pansion.Unfortunately, the mid sfa stent failed to fully expand despite balloon post-dilation using high pressure inflation.At this point, decision was made to terminate the procedure and bring the patient back for ivl treatment of the heavily calcified cfa lesion and mid sfa sue in 2 weeks.At the follow up procedure, selective angiography of the right lower extremity confirmed the heavily calcified lesion involving the cfa.The sfa was patent with the under-expanded stent in the distal vessel due to significant compression from extrinsic calcium leading to moderate sr.The pa was patent with mild diffuse disease and single vessel runoff below the knee via the peroneal artery.The patient did not experience any adverse consequences.

Manufacturer Narrative

Section h6 updated to reflect completion of investigation.Patient and event information were requested, but author declined to provide any details.As a result, further investigation was not possible.

Manufacturer Narrative

Added g4.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15221611
• MDR Text Key: 298220877
• Report Number: 2017233-2022-03209
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Male