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

Catalog Number PAHR052502E

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/17/2021

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2021, the patient underwent endovascular treatment for an occluded lesion in the distal superficial femoral artery (sfa) and proximal popliteal artery of the left limb as verified by imaging.Two gore® viabahn® endoprostheses with propaten bioactive surface (vsx-devices) were implanted in the distal sfa in the left leg.Post-dilation was performed and at the end of the procedure the devices were patent.The patient tolerated the procedure.On (b)(6) 2021 an adverse event happened, as there was an acute vsx-device occlusion.Therefore, an endovascular repeat intervention was performed on (b)(6) 2021.During the intervention there were procedural complications as the crural vessels occluded.Therefore, on (b)(6) a mechanical thrombectomy had to be performed.At the end of the procedure the vsx-devices patency was restored.

Manufacturer Narrative

Other code: as the device remains implanted, no further investigation on the device can be performed.A product history review and, if images are available, an imaging evaluation will be performed.Please notice that the first gore® viabahn® endoprosthesis with propaten bioactive surface was reported under manufacturer report number 2017233-2022-02670.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Manufacturer Narrative

Product history review: a review of the manufacturing records indicated the device met pre-release specifications.A review of the sterilization records indicated the lot met all pre-release specifications.A review of the heparin coating records indicated the device met pre-release specifications.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.The physician was asked for the root cause of the occlusion, if there is a relation between the comorbidities or the patient history of the patient and if the reported event is device-related.It was stated that the root cause is unknown, as no edge stenosis was visible after the alteplase treatment.A relation to the comorbidities or the patient history or the device could not be excluded, as the angiography mentioned a relatively small sfa and the whole device was occluded.With the information provided to gore, the cause could not be established.In the instruction for use for the gore® viabahn® endoprosthesis with propaten bioactive surface the following is stated: hazards and adverse events: procedure related: as with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be expected.These complications include, but are not limited to: thrombosis, occlusion.Device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: thrombosis or occlusion.

• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13279514
• MDR Text Key: 286643832
• Report Number: 2017233-2022-02671
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PAHR052502E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2021
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 78 KG