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

Model Number	VBHR060502A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
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.A review of the manufacturing records indicated the device met pre-release specifications.Further information will be provided in final report.
Event or Problem Description
It was reported to gore that during a procedure to treat the superficial femoral artery the gore® viabahn® endoprosthesis with heparin bioactive surface got stuck and the procedure needed to be converted to a cut down procedure to remove the device.
Additional Manufacturer Narrative
The engineering evaluation revealed that the primary reported failure mode of partial device expansion was confirmed upon physical examination of the device.The cause could not be determined with the information and items returned.The observation of a longitudinally compressed endoprosthesis during device evaluation is consistent with the physician¿s reported attempt to pull the device back into the sheath.The observation of a crushed distal tip is consistent with withdrawal efforts, including cutdown and possible interaction with surgical tools.The observation of a deployment line with an end that appeared cut is also consistent with reported surgical intervention to remove the device.As the remaining components of the delivery system were not returned, no further observations could be made in relation to the nature of this complaint, including reported deployment line break.Deployment of the returned device was continued successfully with traction at the endoprosthesis.
Additional Manufacturer Narrative
Selected both adverse event and product problem within section b1.Event was a product malfunction that resulted in a serious injury.

• 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: 14607194
• Report Number: 2017233-2022-02993
• Device Sequence Number: 5001170
• Product Code: NIP
• UDI-Device Identifier: 00733132622764
• UDI-Public: 00733132622764
• Combination Product (Y/N): Y
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2022

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: 03/08/2023
• Device Model Number: VBHR060502A
• Device Catalogue Number: VBHR060502A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 05/09/2022; 05/09/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 06/13/2022; 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Other
• Patient Sex: Unknown