MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE; NIP

Model Number	VBJR080202A
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	07/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2020, the patient was being treated for stenosis within the renal vein using two gore® viabahn® endoprostheses.A asahi grand slam guidewire was used to complete the procedure the viabahn (22283464) was advanced to its intended location however, during deployment the device moved an unknown amount.An additional viabahn (22047427) was implanted for extension.Both stents were post dilated with an 8x40 pta balloon.After ballooning, a 6fr pigtail catheter was placed in the vein to perform an angiogram.Both ivus and the subsequent angiogram confirmed the stents were in the desired location.The pigtail catheter was removed, however upon removal both stents were pulled from the renal vein into the inferior vena cava.The stents then migrated into two different locations of the heart.Both viabahns were retrieved by a 25mm snare and pulled out of the body through a 24fr dyrseal sheath.The stents reportedly looked to be undamaged and it was determined by the physician that nothing was left behind in the patient¿s body.Another viabahn was used to complete the case.The patient tolerated the procedure.
Additional Manufacturer Narrative
As no coverage of any vessel was reported, this event will be considered non-reportable and this medwatch report will be retracted.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
• Common Device Name: NIP
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10457653
• Report Number: 2017233-2020-01181
• Device Sequence Number: 2676528
• Product Code: PFV
• UDI-Device Identifier: 00733132623808
• UDI-Public: 00733132623808
• Combination Product (Y/N): Y
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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: 02/22/2023
• Device Model Number: VBJR080202A
• Device Catalogue Number: VBJR080202A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 01/19/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention