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

Model Number	VBJR070502A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The following was reported to gore: the patient presented for an emergent aaa case because of aortic rupture.The gore® viabahn® endoprosthesis was placed in one of the renals to be used as a snorkel.As the deployment line was being pulled the deployment line could not be pulled.The device was snagged from the groin and removed.During removal the device began to open.The device was fully removed from the patient.
Additional Manufacturer Narrative
2017233-2020-00039.Discussions with the doctor revealed the deployment line did not break.Medwatch #2017233-2020-00039 was sent in error.Additional received information determined that this event is not reportable to the fda and therefore the medwatch (and supplementals) will be retracted.Type of reportable event.
Additional Manufacturer Narrative
Results code 1.Review of the manufacturing records indicated the device met pre-release specifications.The investigation is ongoing.
Additional Manufacturer Narrative
Corrected data: h6.Method code 2.H6.Conclusions code 1.Additional manufacturer narrative: there was no device or images available for evaluation.The device history and manufacturing machine files were evaluated for non-routine maintenance that could contribute to this event.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 could be identified.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9595999
• Report Number: 2017233-2020-00039
• Device Sequence Number: 11557231
• Product Code: PFV
• UDI-Device Identifier: 00733132623761
• UDI-Public: 00733132623761
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2022
• Device Model Number: VBJR070502A
• Device Catalogue Number: VBJR070502A
• Device Lot Number: 21262796
• 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; Not provided
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 01/31/2020; 02/18/2020; 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1