MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS; STENT, ILIAC

Catalog Number	BXAL083901A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	11/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device: bxal083901a, no lot number or udi information is available.14 fr.Gore® dryseal flex sheath dsf1433, lot # 17734599 being reported separately.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 a patient was undergoing treatment of an innominate artery ulcerated lesion with a gore® viabahn® vbx balloon expandable endoprosthesis.Plaque was present at the origin of the artery.The device was modified prior to insertion into the patient by partially deploying the device to remove it from the balloon, then reloading it onto an atlas balloon, (16mm x 40mm).This device was then back fed through a 10 fr.Boston scientific super sheath.The common carotid artery was exposed and clamped.The pre-sheathed device was then inserted through a 14 fr.Gore® dryseal flex sheath.It was advanced up to the aorta, toward the target lesion, but it was noted the balloon was not centered.This device was then successfully snared and removed from the patient.It was then reloaded onto the atlas balloon and advanced again.Deployment was successful, although the device accordioned in the center.This led to shortening of the device.In order to complete the treatment length, another vbx device was modified and advanced, but it came off the balloon and embolized all the way down to the left common femoral artery where it was successfully snared and removed from the patient.As the patient was beginning to wake up, he was not able to move his left extremities.A ct revealed decreased perfusion to the brain.Tissue plasminogen activator (tpa) was administered.The patient may have exhibited some slight movement on the left side following tpa, but it was not significant.A ct was taken and it reportedly showed something described as a piece of plastic in the brain.The patient was transferred to a stroke unit.
Additional Manufacturer Narrative
Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8158420
• Report Number: 2017233-2018-00762
• Device Sequence Number: 11134698
• Product Code: NIO
• UDI-Device Identifier: 00733132637812
• UDI-Public: 00733132637812
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2021
• Device Catalogue Number: BXAL083901A
• Device Lot Number: 18786318
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/08/2019; 03/11/2019; 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 85 YR