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

Catalog Number	VBH130502A
Medical Device Problem Codes	Failure to Unfold or Unwrap (1669); Activation Failure (3270)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records indicated the device met pre-release specifications.The investigation is ongoing.
Event or Problem Description
The following was reported to gore by the or nurse: the gore® viabahn® endoprosthesis with heparin coating did not completely open.
Additional Manufacturer Narrative
Corrected data: b5.Describe event or problem.
Event or Problem Description
The following was reported to gore by the doctor: the patient presented for open arch repair.The doctor placed the gore® viabahn® endoprosthesis in the innominate artery.When the deployment line was pulled, the doctor observed it to appear to unravel.The gore® viabahn® endoprosthesis did not completely open.The doctor continued the repair using open technique.
Additional Manufacturer Narrative
Additional manufacturer narrative: d10: returned to manufacturer on: (mm/dd/yyyy) examination of the returned device revealed the following: the endoprosthesis, delivery catheter, and part of the deployment line were returned; the deployment knob with a section of the deployment line was not returned; the deployment line was broken with four single fibers coming out of the body of the catheter, approximately 7 cm from the hub; the first fiber measured 34 cm and was intertwined with another fiber measuring approximately 6 cm; the other two fibers measured approximately 56 and 40 cm.All fibers appeared to be fraying at the ends; the deployment line near the endoprosthesis was unremarkable; the endoprosthesis was partially expanded approximately 2 cm; there were 2 cm of the endoprosthesis still constrained by the inner braided constraining line; deployment was able to be continued with traction on the deployment line at the endoprosthesis; the remainder of the device was unremarkable.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.Corrected data: h6: results code 2 h6: conclusions code 1 h10: device available for evaluation? (do not send to fda).

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8750353
• Report Number: 2017233-2019-00490
• Device Sequence Number: 19417801
• Product Code: PFV
• UDI-Device Identifier: 00733132623280
• UDI-Public: 00733132623280
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2019

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: 01/06/2022
• Device Catalogue Number: VBH130502A
• Device Lot Number: 20453985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• 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: 07/01/2019
• Supplement Report FDA Received Date: 07/26/2019; 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR