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

Catalog Number VBC111002

Device Problem Insufficient Information (3190)

Patient Problems Infarction, Cerebral (1771); Death (1802); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)

Event Date 01/30/2015

Event Type  Death  

Event Description

On evening of (b)(6) 2015, the patient was to be implanted with a gore® viabahn® endoprosthesis (vbc111002/13049397) together with 4 gore® excluder® endoprosthesis for treatment of an abdominal aortic aneurysm by using the sandwich technique.The gore® viabahn® device was to be deployed in the left internal iliac artery as branch graft.A local anesthesia was administrated during the procedure since the patient took a small amount of food.The femoral arteries were punctured first for the excluder devices access.When accessing the left humeral artery with a vein sheath for inserting the viabahn® device, it was reported that an obvious blood loss at the punch site was observed, the patient¿s blood pressure, breathing and o2 saturation were sharply declined.The patient was rescued by cardiac compression and administering pressor drugs to stabilize the situation in order to continue the procedure.The excluder® and viabahn® devices were deployed in the target lesions without any endoleaks.During post-deployment angiography, it was reported that the patient complained of being fidgety and dry mouth then the patient rapidly declined and was moved to icu for monitoring.The patient reportedly expired on the afternoon of (b)(6) 2015.It was stated that a large area cerebral infarction was considered as the cause of death after a hospital consultation.During the operation, a branch of the left internal iliac artery was pierced by a guide wire accessing from the left humeral artery down to the left internal iliac artery and then repaired by occluding it with a spring coil.

Manufacturer Narrative

Event Description

On evening of (b)(6) 2015, the patient was to be implanted with a gore® viabahn® endoprosthesis ((b)(6)) together with 4 gore® excluder® endoprosthesis for treatment of an abdominal aortic aneurysm by using the sandwich technique.The gore® viabahn® device was to be deployed in the left internal iliac artery as branch graft.A local anesthesia was administrated during the procedure since the patient took a small amount of food.The femoral arteries were punctured first for the excluder devices access.When accessing the left humeral artery for inserting the viabahn® device, it was reported that an obvious blood loss was observed, the patient¿s blood pressure, breathing and o2 saturation were sharply declined.The patient was rescued by cardiac compression and administering pressor drugs to stabilize the situation in order to continue the procedure.The excluder® and viabahn® devices were deployed in the target lesions without any endoleaks.During post-deployment angiography, it was reported that the patient complained of being fidgety and dry mouth then the patient rapidly declined and was moved to icu for monitoring.The patient reportedly expired on the afternoon of (b)(6) 2015.It was stated that a large area cerebral infarction was considered as the cause of death after a hospital consultation.During the operation, a branch of the internal iliac artery was pierced by a guide wire and repaired by occluding it with a spring coil.

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.The concomitant medical product were gore® excluder® endoprosthesis (item#:pxt311417/lot#:12684669, item#:pxc161000/ lot#:11799119, item#:pxc141000/ lot#:13181263, item#:pxc141200/ lot#:13194489), and the therapy date was (b)(6) 2015.

• 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 86001
• Manufacturer Contact: helen huang ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4555841
• MDR Text Key: 5451965
• Report Number: 2017233-2015-00116
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 03/03/2015

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 Expiration Date: 08/13/2017
• Device Catalogue Number: VBC111002
• Device Lot Number: 13049397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2014
• 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): Death
• Patient Age: 70 YR
• Patient Weight: 75