MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® VIABAHN® ENDOPROSTHESIS; NIP

Catalog Number JHJR062502J

Device Problems Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)

Patient Problem Occlusion (1984)

Event Type  Death  

Manufacturer Narrative

(b)(4).According to the gore® viabahn® endoprosthesis instructions for use (ifu), device-related complications and adverse events include, but are not limited to thrombosis or occlusion of device and death.

Event Description

On (b)(6) 2018, percutaneous transluminal angioplasty (pta) was performed to repair an occlusion of the right superficial femoral artery.It was reported the condition of the below knee run-off vessels was poor.Therefore, it was reportedly planned to implant a bare metal stent.When the.035 guidewire was advanced with the knuckle technique, an arteriovenous fistula was unintentionally created.It was reported a bare metal stent (zilber ptx, 6 mm x 15 cm) was implanted near the run-off vessels, and a gore® viabahn® endoprosthesis with heparin bioactive surface was implanted proximal to the stent.On (b)(6) 2018, ultrasound imaging confirmed that the endoprosthesis was occluded.The physician reported that aspirin and plavix were prescribed as dual antiplatelet therapy (dapt) after the initial procedure, however, the patient was not able to even take a meal and dapt was not actually performed.On (b)(6) 2018, re-intervention was performed to treat the occlusion.It was reported the plan was to implant another gore® viabahn® endoprosthesis with heparin bioactive surface.However, due to the large amount of thrombus, there was no space to implant an additional endoprosthesis.Therefore, decision was made to perform catheter-directed thrombolysis (cdt).Cdt was started with urokinase 60,000 units during the procedure, and the thrombus started to dissolve.Cdt was continued with urokinase 10,000 units per hour for three days.On (b)(6) 2018, bleeding from the gallbladder was observed.The patient's vital sign suddenly changed, and the patient expired.It was reported the cause of death was hemorrhagic shock.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marcos ayala ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7500795
• MDR Text Key: 107818843
• Report Number: 2017233-2018-00264
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2020
• Device Catalogue Number: JHJR062502J
• Device Lot Number: 17259529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2017
• 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): Death