MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE PROPATEN VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number H060040A

Device Problem Complete Blockage (1094)

Patient Problem Thrombosis (2100)

Event Date 01/10/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: concomitant medications were sevelamer carbonate, ergocalciferol, vitamin b12, epoetin alfa, acetylsalicylic acid, atorvastatin, vitamin b complex, insulin glargine, insulin aspart, omeprazole, bifidobacterium longum/lactobacillus acidophilus/lactobacillus rhamnosus, and cefazolin sodium.In addition, other relevant history lists patient's medical history.

Event Description

The following was to reported to gore by (b)(6) in reference to a non-gore clinical trial study that involves gore® propaten® vascular graft as study conduits: on (b)(6) 2016, a gore® propaten® vascular graft was placed in the subject's left upper arm as a study conduit for dialysis access.On (b)(6) 2017, the subject experienced thrombosis of the vascular access.A doppler ultrasound (us) was performed and no flow through the study conduit was noted; there was no thrill, bruit, or clinical dilatation present.On (b)(6) 2017, a left arm fistulogram, us guided puncture of the study conduit, a mechanical thrombectomy with infusion of tissue plasminogen activator (tpa), and stenting (8x10) of a venous anastomosis were performed.Two mg of tpa was instilled into the study conduit, and 5000u of systemic heparin was then administered.A 6mm x 6cm balloon was used to macerate the thrombus within the graft and the central veins.An arterial plug was removed with a fogarty balloon catheter.Significant stenosis at the venous anastomosis was noted and addressed with a 6mm balloon.An angiogram was performed and demonstrated extravasation at this area.A 6fr sheath was exchanged for an 8fr sheath.No residual stenosis and excellent thrill within the study conduit was noted.On (b)(6) 2017, the study conduit was considered suitable for regular use for dialysis.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: genevieve begay ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8596398
• MDR Text Key: 144596709
• Report Number: 2017233-2019-00329
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: H060040A
• 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): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 93