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

Catalog Number IRTH064040J

Device Problem Occlusion Within Device (1423)

Patient Problem No Code Available (3191)

Event Date 05/15/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2017 will be determined as the date of event.Date of device implant and date of device explant: (b)(6) 2017 will be determined as the date of device implant and (b)(6) 2017 as the date of device explant.Please refer to the following rationale: the initial implant procedure was performed in (b)(6) and the graft replacement procedure was performed in (b)(6) ; (b)(6) 2017 will be determined as the date of device implant and (b)(6) 2017 as the date of event as well as that of device explant.A review of the manufacturing records for the device could not be conducted as the lot number of the device was not available.

Event Description

In the (b)(6) 2017 (exact date is unknown), the patient underwent a shunt-preparation procedure to treat renal insufficiency.A gore® propaten® vascular graft (irth064040j with an unknown lot number) was implanted in the patient¿s right upper arm.Later in a follow-up study, an echography revealed that a portion of the existing graft had undulated in its shape and occluded.In the middle of (b)(6) 2017 (exact date is unknown), the existing graft was replaced with another vascular graft to repair the graft occlusion.The patient tolerated the procedure.

• 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: yutaka uchiya ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6649491
• MDR Text Key: 77823166
• Report Number: 2017233-2017-00307
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062161
• 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: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IRTH064040J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 74 YR