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

Model Number	VBH100502A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
On (b)(6) 2020, the patient underwent treatment for a popliteal artery occlusion using gore® viabahn® endoprostheses.It was reported a gore® viabahn® endoprosthesis (vbh100502a/20466865) was advanced into its intended location.Reportedly the deployment line was pulled, however, the device failed to completely expand leaving a portion of the device constrained.The physician ballooned the gore® viabahn® endoprosthesis and the device was fully expanded.However, as the deployment catheter was being removed from the patient, it was observed that the popliteal artery had ruptured.The procedure was completed with the physician performing a fem-pop bypass using a vascular graft.The patient tolerated the procedure.The physician stated it is unknown what caused the partial device expansion or the rupture.
Additional Manufacturer Narrative
Engineering evaluation task was performed and the results are: an image was returned; however, it could not be used in the engineering evaluation.10mm x 5cm device: there is no device or images available for evaluation for the 10mm x 5cm device.See further evaluation below.No root cause was found following an engineering evaluation.No anomalies or non-routine maintenance were identified that could be attributed to the failure seen in this event.Therefore, based off of the evaluation performed, no manufacturing cause to which the event could be definitively attributed could be identified.Engineering evaluation conclusion is inconclusive as it relates to the event description.
Additional Manufacturer Narrative
Corrected h6: method code 2 4114.Code 4114 - engineering evaluation task was performed and the results are: an image was returned; however, it could not be used in the engineering evaluation.10mm x 5cm device: there is no device or images available for evaluation for the 10mm x 5cm device.See further evaluation below.No root cause was found following an engineering evaluation.No anomalies or non-routine maintenance were identified that could be attributed to the failure seen in this event.Therefore, based off of the evaluation performed, no manufacturing cause to which the event could be definitively attributed could be identified.Engineering evaluation conclusion is inconclusive as it relates to the event description.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9769531
• Report Number: 2017233-2020-00133
• Device Sequence Number: 2185074
• Product Code: PFV
• UDI-Device Identifier: 00733132623211
• UDI-Public: 00733132623211
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 04/16/2020

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: 03/11/2022
• Device Model Number: VBH100502A
• Device Catalogue Number: VBH100502A
• Device Lot Number: 20466865
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/15/2020; 04/16/2020
• 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: Hospitalization; Required Intervention