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

Model Number	VBJR081002A
Medical Device Problem Codes	Material Separation (1562); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	02/26/2020
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 occlusive treatment.The first 2 gore® viabahn® endoprosthesis were placed without issue.The third gore® viabahn® endoprosthesis was advanced into position and deployment started.The device experienced no expansion and the deployment line broke while being pulled.The doctor was able to back the device back into the sheath and remove it from the patient without issue.Another gore® viabahn® endoprosthesis was successfully advanced and deployed.
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 entire device was returned.-the deployment line appeared to be broken.The section still attached to the deployment knob measured approximately 157 cm, including three single fibers measuring approximately 2.2 cm, 1.3 cm, and 0.4 cm.-approximately 1.9cm of the deployment line was attached to the constraint sleeve including two single fibers measuring 0.3cm and 0.4cm.-the outer braided constraining line was deployed to the tip end of the device.The endoprosthesis was fully constrained by the inner braided constraining line.-the remainder of the device appeared unremarkable.Deployment was able to be continued with traction on the deployment line at the endoprosthesis.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.
Additional Manufacturer Narrative
Medwatch #2017233-2020-00190 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.
Additional Manufacturer Narrative
Type of reportable event.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9843463
• Report Number: 2017233-2020-00190
• Device Sequence Number: 2421515
• Product Code: PFV
• UDI-Device Identifier: 00733132623822
• UDI-Public: 00733132623822
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/23/2020

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: 09/08/2022
• Device Model Number: VBJR081002A
• Device Catalogue Number: VBJR081002A
• Device Lot Number: 21279061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• 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: 03/17/2020
• Supplement Report FDA Received Date: 03/25/2020; 04/21/2020; 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1