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

Model Number	VBJR051002A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	03/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.The investigation is ongoing.
Event or Problem Description
The following was reported to gore: the patient presented for sfa occlusion treatment.The physician chose an up and over approach.Using a flexor® raabe guiding sheath and a.035 glidewire advantage® guidewire, the gore® viabahn® endoprosthesis was advanced into place mid-popliteal.When the deployment line was pulled, it broke.The device was pulled back into the sheath and removed from the patient.The procedure was successfully completed using a second gore® viabahn® endoprosthesis.The device and deployment line were given to the hospital risk manager.
Additional Manufacturer Narrative
Corrected data: h6.- results code 2.H6.- conclusions code 1.Additional manufacturing narrative: examination of the returned device revealed the following: the delivery catheter, deployment knob and deployment line were returned; the deployment line measured approximately 64.3 cm from the deployment knob and included a single fiber measuring approximately 12.3 cm; the remainder of the device was unremarkable.Based on the examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.
Additional Manufacturer Narrative
Corrected date: h1.- type of reportable event.Additional manufacturer narrative: medwatch #2017233-2020-00223 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.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9904331
• Report Number: 2017233-2020-00223
• Device Sequence Number: 2718476
• Product Code: PFV
• UDI-Device Identifier: 00733132623914
• UDI-Public: 00733132623914
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 07/07/2020

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: 05/13/2022
• Device Model Number: VBJR051002A
• Device Catalogue Number: VBJR051002A
• Device Lot Number: 20789270
• 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: 03/31/2020
• Supplement Report FDA Received Date: 06/25/2020; 07/07/2020
• 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: 79 YR