MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

Catalog Number JHJR052502J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Occlusion (1984)

Event Date 12/04/2019

Event Type  Injury  

Manufacturer Narrative

The lot numbers have not been provided.Review and analysis of all available information fails to indicate a potential root cause of the incident as reported to gore, as the lot numbers remain unknown and the devices remain implanted in the patient.

Event Description

On (b)(6) 2019, this patient underwent endovascular treatment using gore® viabahn® endoprosthesis with heparin bioactive surface in the left superficial femoral artery.It was reported a viabahn was implanted approximately 7-8cm distal from the origin of the left superficial femoral artery.Additionally, one eluvia drug-eluting stent (6mm×4cm) was attempted to be implanted from the origin of the left superficial femoral artery.However, it was reportedly implanted 2 cm distal from the origin of the left superficial femoral artery.It was reported to bridge the remaining gap between the two devices, an additional eluvia drug-eluting stent (6mm×8cm) was implanted.Intra procedural imaging identified there was stenosis around the distal end of viabahn.Reportedly as there was blood flow blood flow through the device, the physician decided to monitor the patient without any additional treatment.On b)(6) 2019, an occlusion of the viabahn was reportedly observed.On (b)(6) 2019, this patient underwent additional treatment.It was reported urokinase could not be used because the thrombus was solid more than expected.As a treatment, a viabahn (5 mm × 25 cm) was placed to cover the stenosis, and then a viabahn (5 mm × 10 cm) was overlapped at the sfa origin (within the eluvia stent).Post ballooning was reportedly implemented at the edge of the device.It was reportedly an improvement of blood flow was confirmed.The physician reportedly stated at the index procedure, there was stenosis identified on the distal side of viabahn.Reportedly the stenosis most likely caused the post operative occlusion.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• 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; 9285263030
• MDR Report Key: 9496733
• MDR Text Key: 183125413
• Report Number: 2017233-2019-01257
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JHJR052502J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• 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): Hospitalization; Required Intervention
• Patient Age: 87 YR