MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number VBJ050502

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 04/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The following information was reported to gore: on (b)(6) 2017 a patient was undergoing treatment of an abdominal aortic aneurysm with a medtronic device with suprarenal fixation anchors with snorkeling to a left accessory renal artery with a gore® viabahn® endoprosthesis.Following placement of the medtronic main body, the viabahn was advanced and deployed.When the delivery catheter was being removed, it was catching on something, very proximal to the deployed device, and suspected to be the barbs of the medtronic device.An attempt to resheath the device was made, by pulling back on the delivery catheter while pushing forward with the sheath.The sheath then began catching on the barbs and the medtronic device became pushed upward.Eventually the viabahn delivery catheter and sheath were removed, a radiopaque marker was visible on imaging which could be from a piece of the terumo sheath.In addition the leading olive of the delivery catheter broke off and remains impinged within the barbs of the medtronic device.Attempts to snare the olive were made, but were not successful.Renal function was shown to be compromised, by lack of urine output, and the patient was converted to a bilateral renal artery bypass procedure.As of (b)(6) 2017 the patient was in the icu producing little urine.

Manufacturer Narrative

Conclusion code: several requests were made to obtain the device for analysis but these attempts were unsuccessful.

Manufacturer Narrative

Corrected date of event.

Event Description

The following information was reported to gore: on (b)(6) 2017 a patient was undergoing treatment of an abdominal aortic aneurysm with a medtronic device with suprarenal fixation anchors with snorkeling to a left accessory renal artery with a gore® viabahn® endoprosthesis.Following placement of the medtronic main body, the viabahn was advanced and deployed.When the delivery catheter was being removed, it was catching on something, very proximal to the deployed device, and suspected to be the barbs of the medtronic device.An attempt to resheath the device was made, by pulling back on the delivery catheter while pushing forward with the sheath.The sheath then began catching on the barbs and the medtronic device became pushed upward.Eventually the viabahn delivery catheter and sheath were removed, a radiopaque marker was visible on imaging which could be from a piece of the terumo sheath.In addition the leading olive of the delivery catheter broke off and remains impinged within the barbs of the medtronic device.Attempts to snare the olive were made, but were not successful.Renal function was shown to be compromised, by lack of urine output, and the patient was converted to a bilateral renal artery bypass procedure.As of (b)(6) 2017 the patient was in the icu producing little urine.

Manufacturer Narrative

Updated with event date correction.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6575806
• MDR Text Key: 75466460
• Report Number: 2017233-2017-00260
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2017
• Device Catalogue Number: VBJ050502
• Device Lot Number: 12926850
• 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: 05/27/2014
• 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; Other; Required Intervention
• Patient Age: 78 YR