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

Catalog Number H060040A

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombosis (2100)

Event Date 09/09/2016

Event Type  Injury  

Manufacturer Narrative

No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.Concomitant medications were aspirin (acetylsalicylic acid), amlodipine, simvastatin, hydralazine, clonidine, carvedilol, renvela (sevelamer carbonate), sensipar (cinacalcet hydrochloride), and nephro-vite (ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride).

Event Description

It was reported to gore that on (b)(6) 2016, a study patient was implanted with a gore propaten vascular graft in the right upper arm as a conduit.The patient was believed to be on plavix (clopidogrel) and therefore was not started on aspirin as part of the discharge orders.On (b)(6) 2016, the patient was not taking aspirin and patient denied taking plavix.The patient was started on aspirin 81 mg on (b)(6) 2016.On (b)(6) 2016, the patient's graft was found to be occluded.The patient had a procedure of a fistulogram, mechanical thrombectomy and installation of tissue plasminogen activator (tpa) and heparin for a thrombosis of his vascular study conduit.A balloon angioplasty using an 8mm x 6cm balloon was performed to macerate the thrombus within the conduit.Heparin and tpa was instilled and a venography revealed normal outflow and a good thrill was restored.The occlusion was resolved successfully on (b)(6) 2016.On (b)(6) 2016, the study patient experienced thrombosis in the implanted gore propaten vascular graft.On the same date, the patient underwent resection of the arteriovenous (av) graft, placement of a new 6mm gore propaten vascular graft, and the event was resolved.

Manufacturer Narrative

Additional information was received from complainant / user facility.

Event Description

On (b)(6) 2016, the patient underwent resection of the arteriovenous (av) graft and placement of a new 6 mm av graft in the right, brachioaxillary region due to poor incorporation of the graft.

Manufacturer Narrative

Explant date - date was entered based on user facility information reporting a resection of the graft.It is unknown if all or part of the graft was explanted; it was not returned to gore for evaluation.

• 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; flagstaff, AZ ; 9285263030
• MDR Report Key: 5997289
• MDR Text Key: 56398804
• Report Number: 2017233-2016-00770
• 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: user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/19/2016; 11/15/2016
• 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: 46 YR
• Patient Weight: 83