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

Model Number	VBH100502A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that the lot met all pre-release specifications.
Event or Problem Description
On (b)(6) 2019, the patient was implanted with gore® viabahn® endoprostheses to treat a popliteal aneurysm.It was reported a.035 guidewire was used during the procedure.The sheath brand and size are reportedly unknown.It was reported during deployment, the deployment line broke and the device was partially opened approximately 98 percent.The physician reportedly stated is unknown what caused the deployment line to break.It was reported the catheter was cut in order to gain access to the remaining deployment line.The deployment line was pulled and the device was reportedly completely opened.However, a portion of the deployment line remained in the patient¿s body and could not be retrieved.The procedure was completed.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: corrected conclusion code.Engineering evaluation states, based on the evaluation of the device, the following observations were made: the deployment knob, deployment line, and delivery catheter were returned.There was approximately 148 cm of deployment line attached to the deployment knob with two 5 cm single fibers coming off of the end of the deployment line.The delivery catheter appeared cut and was returned in two sections.The first section included the hub with the shrink sleeve.The second section was approximately 123 cm of delivery catheter including the distal shaft, upon which the endoprosthesis was mounted, and the distal tip.The remainder of the device was unremarkable.Engineering evaluation conclusion(s) are: deployment line broken.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9500958
• Report Number: 2017233-2019-01261
• Device Sequence Number: 13973188
• Product Code: PFV
• UDI-Device Identifier: 00733132623211
• UDI-Public: 00733132623211
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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: 06/02/2022
• Device Model Number: VBH100502A
• Device Catalogue Number: VBH100502A
• Device Lot Number: 20865667
• 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
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 115