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

Model Number	VBJR051002A
Medical Device Problem Codes	Failure to Unfold or Unwrap (1669); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional manufacturer narrative: review of the manufacturing records indicated the device met pre-release specifications.The device was not returned.Consequently, a direct product analysis was not possible.All information has been placed on file for use in tracking and trending.
Event or Problem Description
The following information was provided to gore: the patient presented with cto in the right sfa/proximal popliteal.The physician gained access through the left groin and performed up and over approach with 6 fr, 45 cm long sheath.Additionally, the physician gained pedal access and established a through and through wire.He then pre-dilated the lesion with a 5mm balloon, stating the pre-dilation looked good.The doctor alleged he experienced difficulty deploying the gore® viabahn® endoprosthesis and used the 2nd access point (pedal) to balloon assist the expansion of the device to remove of the catheter.The doctor also reported that during the balloon inflate/pull process, the gore® viabahn® endoprosthesis moved into the iliac artery partially covering the hypogastric artery and the profunda artery.At the completion of the procedure, the physician confirmed flow into the internal iliac and the profunda.The patient is reported to be fine.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9661139
• Report Number: 2017233-2020-00067
• Device Sequence Number: 3392757
• Product Code: PFV
• UDI-Device Identifier: 00733132623914
• UDI-Public: 00733132623914
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 01/13/2020

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: 06/30/2021
• Device Model Number: VBJR051002A
• Device Catalogue Number: VBJR051002A
• Device Lot Number: 18525830
• 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: 02/03/2020
• 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
• Patient Age: 82 YR