MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number	VBC081002
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Imaging evaluation results.Intended use / indications state, the gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference vessel diameters ranging from 4.0 ¿ 7.5 mm.The gore® viabahn® endoprosthesis is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions with reference vessel diameters ranging from 4.0 ¿ 12 mm.W.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications where the endoprosthesis may experience repeated and extreme flexion, such as across the popliteal fossa and the antecubital fossa.Clinical conditions such as excessive bending, tortuosity, and / or repeated and extreme flexion may result in compromised performance or failure of the endoprosthesis.
Event or Problem Description
It was reported to gore that a 8mm x 10cm gore® viabahn® endoprosthesis was to be implanted for treatment of the splenic artery aneurysm.Because of the excessively tortuous vessels, resistance was reportedly felt during device advancement.The splenic artery aneurysm was ruptured due to the excessive force used during attempts to get the viabahn device to treatment site.The constrained gore® viabahn® endoprosthesis was retracted out of the patient.Coiling was done to stop the bleeding and the patient was transferred to the icu for surgical intervention.The patient tolerated the procedure.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8193428
• Report Number: 2017233-2018-00795
• Device Sequence Number: 2141997
• Product Code: PFV
• UDI-Device Identifier: 00733132614608
• UDI-Public: 00733132614608
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2021
• Device Catalogue Number: VBC081002
• Device Lot Number: 18278635
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/24/2018
• 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: Other; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 70