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

Catalog Number H060040A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Ischemia (1942); Thrombosis (2100)

Event Date 05/30/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, a gore® propaten® vascular graft was implanted in the patient¿s left upper arm.On (b)(6) 2017, 1 day after the gore® propaten® vascular graft was implanted, the patient experienced steal syndrome (intensity: severe) which prolonged the hospitalization.The medical device stenosis was treated via minimally-invasive limited ligation endoluminal-assisted revision (miller) procedure under local anesthesia.Post-procedure, significant improvement in the palm was seen via doppler signal over the leakage.Bruit was present, and the event was considered resolved on the same day.On (b)(6) 2017, the patient was discharged from the hospital.

• 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: barbara ulrich ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8071609
• MDR Text Key: 127206928
• Report Number: 2017233-2018-00694
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 11/06/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2018
• 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: 76 YR
• Patient Weight: 84