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

Catalog Number H060040A

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Hematoma (1884); Unspecified Infection (1930)

Event Date 02/21/2017

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).Review of device manufacturing and sterilization record history confirmed device met pre-release specifications.The device was retained at user facility.Therefore, direct product analysis was not possible.

Event Description

On (b)(6) 2017, a gore® propaten® vascular graft (standard wall, non-stretch, non-tapered) was implanted in a patient's left forearm as a conduit.On (b)(6) 2017, the patient returned for a wound drainage.The patient required hospitalization for a moderate infection.Intravenous antibiotics were initiated with vancomycin and zosyn (piperacillin sodium, tazobactam sodium).A duplex ultrasound of the left upper extremity was performed with the impression of a hematoma that resulted in a greater than 50% outflow stenosis of the conduit.On (b)(6) 2017, a left antecubital fossa exploration was performed followed by conduit removal and splint application.The conduit was retained for histology and sent for culture.While hospitalized, the patient remained on his routine hemodialysis schedule.The next day, the pico dressing (single use negative pressure wound therapy) was removed and the soft cast was changed to a plaster cast in the orthopedic surgery clinic.The event was considered resolved.On (b)(6) 2017, the patient was discharged from the hospital to a skilled nursing facility for physical therapy.The left arm hard cast flexed at the elbow, there was a palpable radial pulse, fingertips were without numbness, and the hand remained edematous.Wound culture results, obtained intra-operatively, revealed enterococcus faecalis which was susceptible to vancomycin.Zosyn was discontinued and vancomycin 500 mg was to continue for one additional week on the dialysis days.

Manufacturer Narrative

Updated with additional information obtained about patient medical history and laboratory results.

• Brand Name: GORE PROPATEN® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6453964
• MDR Text Key: 71528249
• Report Number: 2017233-2017-00188
• 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,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2020
• Device Catalogue Number: H060040A
• Device Lot Number: 5371239PP005
• 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: 10/11/2016
• 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: 78 YR
• Patient Weight: 68