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

Model Number	VBJR070202A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to gore that during a procedure to treat the celiac artery while using a 7 fr oscar steerable sheath with a 0.18" v18 boston scientific guidewire the gore® viabahn® endoprosthesis with heparin bioactive surface was unable to cross the lesion.Reportedly the physician did not pre-dilate the lesion.It was reported that when the physician was attempting to pull the device back through the sheath, the device tip got hung up on the oscar sheath and started to partially deploy.Reportedly the physician attempted to pull the sheath and device delivery system out of the right common femoral artery and the device deployed in the right external iliac artery.It was reported that the blue olive tip of the delivery system came off and lodged in the internal iliac artery.Reportedly the physician closed and stated that he may attempt to bring her back for another procedure at a later date.
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.Due to an unknown lot/serial number and no device return, an investigation could not be performed.
Additional Manufacturer Narrative
Updated the investigation conclusion codes.
Event or Problem Description
On (b)(6) 2022, patient underwent a procedure to the celiac artery using the gore® viabahn® endoprosthesis with heparin bioactive surface with a 7 fr oscar steerable sheath with a 0.18" v18 boston scientific guidewire.During the procedure the physician was attempting to pull the device back through the sheath, the device tip got hung up on the oscar sheath and started to partially deploy.The physician then attempted to pull the sheath and device delivery system out of the right common femoral artery and the device successfully deployed in the unintended location of the right external iliac artery.At that time, the blue olive tip of the delivery system came off and lodged in the internal iliac artery.No runoff vessels were covered as a result of the unintentional deployment location.The physician then closed and stated that he may attempt to bring her back for another procedure at a later date.It was noted that the physician did not pre-dilate the lesion.On (b)(6) 2022, the patient had a reintervention and the physician placed a 7mmx2.5cm vsx and 7mmx19mm vbx in the celiac.Patient tolerated the procedure.
Additional Manufacturer Narrative
Updated a1.Patient's initials obtained.Updated d4.Device serial number obtained.Updated h6.Analysis of production records: a review of the manufacturing records indicated the device met pre-release specifications.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: spencer deboard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14518520
• Report Number: 2017233-2022-02967
• Device Sequence Number: 5502880
• Product Code: NIP
• UDI-Device Identifier: 00733132623754
• UDI-Public: 00733132623754
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: VBJR070202A
• Device Catalogue Number: VBJR070202A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 05/05/2022; 09/30/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 08/17/2022; 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Life Threatening
• Patient Sex: Unknown